1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX
FDA 510(k) clearance K014115 · decided 2002-02-27
Clearance details
- K-number
- K014115
- Device name
- 1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX
- Applicant
- Portex, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-12-14
- Decision date
- 2002-02-27
- Days to decision
- 75 days
- Clearance type
- Traditional
- Product code
- BTM
- Device class
- 2
- Regulation number
- 868.5915
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Keene, NH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Portex 1st Response Adult Manual Resuscitators Ref: 8506P recall (Z-0808-03) | Sims Portex Inc. | 2003-05-22 |
| Portex 1st Response Adult Manual Resuscitators Ref: 8500P recall (Z-0809-03) | Sims Portex Inc. | 2003-05-22 |
| Portex 1st Response Adult Manual Resuscitators Ref: 8503P recall (Z-0810-03) | Sims Portex Inc. | 2003-05-22 |