FDA device listing
BOOMCARE PG-IRT1603 = PG-IRT1603,bt-degree IR PG-IRT1602,ByFlo Products Inc. PG-IRT1602,caring mill…
FDA device listing 1067467948 · Shenzhen Pango Medical Electronics Co., Ltd
Key facts
| Proprietary names | BOOMCARE PG-IRT1603 = PG-IRT1603,bt-degree IR PG-IRT1602,ByFlo Products Inc. PG-IRT1602,caring mill PG-IRT1603,Dr.ProtekT PG-IRT1603 = PG-IRT1603,Electronic Thermometer AT11=PG-IRT1603,First 5 California PG-IRT1602 = PG-IRT1602,infrared ear/forehead thermometer EDM08-MPBD = PG-IRT1603,Infrared thermometer PG-IRT1601,Infrared thermometer PG-IRT1602,Infrared thermometer PG-IRT1603,Infrared… |
|---|---|
| Owner/operator | Shenzhen Pango Medical Electronics Co., Ltd |
| Owner/operator number | 10037877 |
| Premarket submissions | K182597 |
| Product codes | FLL |
| Device names | FLL - Continuous Measurement Thermometer |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.2910 |
| Review panels | General Hospital |
| Registered establishments | Shenzhen Pango Medical Electronics Co., Ltd |
| Establishment registrations | 3006792041 |
| FEI numbers | 3006792041 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database