DRTS IMAGE INTENSIFIER DRAPE
FDA 510(k) clearance K973073 · decided 1997-10-08
Clearance details
- K-number
- K973073
- Device name
- DRTS IMAGE INTENSIFIER DRAPE
- Applicant
- Minrad, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-08-18
- Decision date
- 1997-10-08
- Days to decision
- 51 days
- Clearance type
- Traditional
- Product code
- JAA
- Device class
- 2
- Regulation number
- 892.1650
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Orchard Park, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.