AMERICAN BENTLEY OXYGENATOR MAX-2
FDA 510(k) clearance K851035 · decided 1985-05-16
Clearance details
- K-number
- K851035
- Device name
- AMERICAN BENTLEY OXYGENATOR MAX-2
- Applicant
- American Bentley
- Decision
- Substantially Equivalent
- Date received
- 1985-03-13
- Decision date
- 1985-05-16
- Days to decision
- 64 days
- Clearance type
- Traditional
- Product code
- DTZ
- Device class
- 2
- Regulation number
- 870.4350
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.