SALTIME VISCOMETER
FDA 510(k) clearance K936006 · decided 1996-02-09
Clearance details
- K-number
- K936006
- Device name
- SALTIME VISCOMETER
- Applicant
- Harold J. Kosasky, M.D.
- Decision
- Substantially Equivalent
- Date received
- 1993-12-15
- Decision date
- 1996-02-09
- Days to decision
- 786 days
- Clearance type
- Traditional
- Product code
- LHZ
- Device class
- 1
- Regulation number
- 884.1040
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Chestnut Hill, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.