HDE
H030004: HEARTSBREATH
FDA Humanitarian Device Exemption · Menssana Research, Inc.
Key facts
| HDE number | H030004 |
|---|---|
| Trade name | HEARTSBREATH |
| Generic name | Test, volatile organic compounds breath analysis |
| Applicant | Menssana Research, Inc. |
| Product code | PAR |
| Approval date | Feb 24, 2004 |
| Docket number | 04M-0084 |
| Notice date | Feb 24, 2004 |
At a glance
- None Supplements
- Feb 24, 2004 Latest supplement decision
- Yes Summary of safety and probable benefit on file
- None UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About HDE approvals
A Humanitarian Device Exemption (HDE) authorizes devices intended to benefit patients with rare diseases or conditions affecting small populations in the United States.
Source: U.S. Food and Drug Administration (FDA), Humanitarian Device Exemption (HDE) database · Source date: