HEPA FILTERED HME
FDA 510(k) clearance K930816 · decided 1993-07-01
Clearance details
- K-number
- K930816
- Device name
- HEPA FILTERED HME
- Applicant
- Intertech Resources, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-02-17
- Decision date
- 1993-07-01
- Days to decision
- 134 days
- Clearance type
- Traditional
- Product code
- CAH
- Device class
- 2
- Regulation number
- 868.5260
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Fort Myers, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Portex HEPA Bacterial /Viral Filter, Non-Latex Ref: 002890 recall (Z-0961-05) | Smiths Medical International Ltd | 2005-07-07 |