510(k) K844173
K844173 is an FDA 510(k) premarket notification submitted by Bionexus, Inc. for the device "FEMTEST". The FDA issued a decision of Substantially Equivalent on August 14, 1985. The device falls under product code HES (Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)), a Class II device regulated under 21 CFR 884.1300. Bionexus, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 14, 1985
- Date Received
- October 25, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)
- Device Class
- Class II
- Regulation Number
- 884.1300
- Review Panel
- OB
- Submission Type