PORTABLE THERAPEUTIC OXYGEN CONCENTRATION SYSTEM (PTOCS)
FDA 510(k) clearance K022684 · decided 2002-09-11
Clearance details
- K-number
- K022684
- Device name
- PORTABLE THERAPEUTIC OXYGEN CONCENTRATION SYSTEM (PTOCS)
- Applicant
- Essex Cryogenics of Missouri, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-08-12
- Decision date
- 2002-09-11
- Days to decision
- 30 days
- Clearance type
- Abbreviated
- Product code
- CAW
- Device class
- 2
- Regulation number
- 868.5440
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- St. Louis, MO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.