MODEL IV 100B-DA INFANT VENTILATOR
FDA 510(k) clearance K833982 · decided 1984-03-05
Clearance details
- K-number
- K833982
- Device name
- MODEL IV 100B-DA INFANT VENTILATOR
- Applicant
- Sechrist Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-11-17
- Decision date
- 1984-03-05
- Days to decision
- 109 days
- Clearance type
- Traditional
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Infant Ventilators with Electronic Manometer. Models IV-100B; IV-200 and IV-200 SAVI. recall (Z-1032-04) | Sechrist Industries Inc | 2004-07-20 |