DISPOSABLE, MANUAL PULMONARY RESUSCITATOR
FDA 510(k) clearance K873286 · decided 1987-10-26
Clearance details
- K-number
- K873286
- Device name
- DISPOSABLE, MANUAL PULMONARY RESUSCITATOR
- Applicant
- Hospitak, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-08-17
- Decision date
- 1987-10-26
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- BTM
- Device class
- 2
- Regulation number
- 868.5915
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Lindenhurst, NY, US
- Third-party review
- No
- Expedited review
- No
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