OMNICORDER BIOSCAN SYSTEM
FDA 510(k) clearance K990416 · decided 1999-12-23
Clearance details
- K-number
- K990416
- Device name
- OMNICORDER BIOSCAN SYSTEM
- Applicant
- Omnicorder Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-02-10
- Decision date
- 1999-12-23
- Days to decision
- 316 days
- Clearance type
- Traditional
- Product code
- LHQ
- Device class
- 1
- Regulation number
- 884.2980
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Stony Brook, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.