COMBISCOPE
FDA 510(k) clearance K852655 · decided 1986-02-21
Clearance details
- K-number
- K852655
- Device name
- COMBISCOPE
- Applicant
- Instrument Technology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-06-24
- Decision date
- 1986-02-21
- Days to decision
- 242 days
- Clearance type
- Traditional
- Product code
- KNG
- Device class
- 2
- Regulation number
- 884.2660
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Mountain View, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.