PUREFILL OXYGEN COMPRESSOR
FDA 510(k) clearance K141967 · decided 2014-11-07
Clearance details
- K-number
- K141967
- Device name
- PUREFILL OXYGEN COMPRESSOR
- Applicant
- Inovo, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-07-21
- Decision date
- 2014-11-07
- Days to decision
- 109 days
- Clearance type
- Traditional
- Product code
- CAW
- Device class
- 2
- Regulation number
- 868.5440
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Lehigh Acres, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.