PMP4 SPIROPRO
FDA 510(k) clearance K050853 · decided 2005-05-04
Clearance details
- K-number
- K050853
- Device name
- PMP4 SPIROPRO
- Applicant
- Card Guard Scientific Survival , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2005-04-04
- Decision date
- 2005-05-04
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- BZH
- Device class
- 2
- Regulation number
- 868.1860
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Rehovot, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.