CPR BIO-BARRIER FACESHEILD
FDA 510(k) clearance K960995 · decided 1997-01-07
Clearance details
- K-number
- K960995
- Device name
- CPR BIO-BARRIER FACESHEILD
- Applicant
- O-Two Systems Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-03-12
- Decision date
- 1997-01-07
- Days to decision
- 301 days
- Clearance type
- Traditional
- Product code
- CBP
- Device class
- 2
- Regulation number
- 868.5870
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Ontario L5s 1c8, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.