DEPLOYABLE OXYGEN CONCENTRATION SYSTEM (DOCS), MODEL 66, DEPLOYABLE OXYGEN CEONCENTRATION
FDA 510(k) clearance K100957 · decided 2011-01-21
Clearance details
- K-number
- K100957
- Device name
- DEPLOYABLE OXYGEN CONCENTRATION SYSTEM (DOCS), MODEL 66, DEPLOYABLE OXYGEN CEONCENTRATION
- Applicant
- Pacific Consolidated Industries, LLC
- Decision
- Substantially Equivalent
- Date received
- 2010-04-07
- Decision date
- 2011-01-21
- Days to decision
- 289 days
- Clearance type
- Traditional
- Product code
- CAW
- Device class
- 2
- Regulation number
- 868.5440
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Riverside, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.