POGS, MODEL 33C
FDA 510(k) clearance K063454 · decided 2007-05-09
Clearance details
- K-number
- K063454
- Device name
- POGS, MODEL 33C
- Applicant
- On Site Gas Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-11-15
- Decision date
- 2007-05-09
- Days to decision
- 175 days
- Clearance type
- Traditional
- Product code
- CAW
- Device class
- 2
- Regulation number
- 868.5440
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Newington, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.