P1808 MOBILE C-ARM IMAGE INTENSIFIER
FDA 510(k) clearance K827087 · decided 1982-03-04
Clearance details
- K-number
- K827087
- Device name
- P1808 MOBILE C-ARM IMAGE INTENSIFIER
- Applicant
- Precise Optics
- Decision
- Substantially Equivalent
- Date received
- 1982-01-22
- Decision date
- 1982-03-04
- Days to decision
- 41 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Bay Shore, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.