MANUAL RESUSCITATOR
FDA 510(k) clearance K895589 · decided 1990-03-30
Clearance details
- K-number
- K895589
- Device name
- MANUAL RESUSCITATOR
- Applicant
- Hudson Oxygen Therapy Sales Co.
- Decision
- Substantially Equivalent
- Date received
- 1989-09-15
- Decision date
- 1990-03-30
- Days to decision
- 196 days
- Clearance type
- Traditional
- Product code
- BTM
- Device class
- 2
- Regulation number
- 868.5915
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Temecula, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.