510(k) K932436
K932436 is an FDA 510(k) premarket notification submitted by Echocath, Inc. for the device "ECHOMARK INTRAUTERINE GUIDING CATHETER". The FDA issued a decision of Substantially Equivalent on November 16, 1995. The device falls under product code MOV (Catheters, Salpingography), a Class II device regulated under 21 CFR 884.4530. Echocath, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 16, 1995
- Date Received
- May 19, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheters, Salpingography
- Device Class
- Class II
- Regulation Number
- 884.4530
- Review Panel
- OB
- Submission Type