O2PAK OXYGEN GENERATOR
FDA 510(k) clearance K120566 · decided 2012-07-24
Clearance details
- K-number
- K120566
- Device name
- O2PAK OXYGEN GENERATOR
- Applicant
- Pacific Precision Products
- Decision
- Substantially Equivalent
- Date received
- 2012-02-27
- Decision date
- 2012-07-24
- Days to decision
- 148 days
- Clearance type
- Traditional
- Product code
- CAW
- Device class
- 2
- Regulation number
- 868.5440
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- Yes
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Recalls involving this device
No recalls on record reference this clearance.