510(k) K936006
K936006 is an FDA 510(k) premarket notification submitted by Harold J. Kosasky, M.D. for the device "SALTIME VISCOMETER". The FDA issued a decision of Substantially Equivalent on February 9, 1996. The device falls under product code LHZ (Viscometer, Mucus, Cervical), a Class I device regulated under 21 CFR 884.1040.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 9, 1996
- Date Received
- December 15, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Viscometer, Mucus, Cervical
- Device Class
- Class I
- Regulation Number
- 884.1040
- Review Panel
- OB
- Submission Type