510(k) K883832
K883832 is an FDA 510(k) premarket notification submitted by Telos Medical Corp. for the device "CATHETER, INTRAUTERINE AND INTRODUCER". The FDA issued a decision of Substantially Equivalent on December 13, 1988. The device falls under product code KXO (Monitor, Pressure, Intrauterine), a Class II device regulated under 21 CFR 884.2700. Telos Medical Corp. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 13, 1988
- Date Received
- September 9, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Pressure, Intrauterine
- Device Class
- Class II
- Regulation Number
- 884.2700
- Review Panel
- OB
- Submission Type