DATEX ENGSTOM MANUAL RESUSCITATOR
FDA 510(k) clearance K970991 · decided 1997-06-16
Clearance details
- K-number
- K970991
- Device name
- DATEX ENGSTOM MANUAL RESUSCITATOR
- Applicant
- Promedic, Inc.
- Decision
- Unknown
- Date received
- 1997-03-19
- Decision date
- 1997-06-16
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- BTM
- Device class
- 2
- Regulation number
- 868.5915
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Mccordsville, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.