510(k) K952033
K952033 is an FDA 510(k) premarket notification submitted by Imagyn Medical, Inc. for the device "IMAGYN HYSTEROSCOPE". The FDA issued a decision of Substantially Equivalent on July 24, 1995. The device falls under product code HIH (Hysteroscope (And Accessories)), a Class II device regulated under 21 CFR 884.1690. Imagyn Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 24, 1995
- Date Received
- May 1, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hysteroscope (And Accessories)
- Device Class
- Class II
- Regulation Number
- 884.1690
- Review Panel
- OB
- Submission Type