510(k) K905495
K905495 is an FDA 510(k) premarket notification submitted by Frigitronics, Inc. for the device "HYSTEROMAT HYSTEROFLATOR HYSTEROSCOPIC INSUFFLATOR". The FDA issued a decision of Substantially Equivalent on April 29, 1991. The device falls under product code HIG (Insufflator, Hysteroscopic), a Class II device regulated under 21 CFR 884.1700. Frigitronics, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 29, 1991
- Date Received
- December 7, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Insufflator, Hysteroscopic
- Device Class
- Class II
- Regulation Number
- 884.1700
- Review Panel
- OB
- Submission Type