510(k) K893770
K893770 is an FDA 510(k) premarket notification submitted by Tokos Medical Corp. for the device "TERM GUARD II DEVICE". The FDA issued a decision of Substantially Equivalent on November 3, 1989. The device falls under product code HFM (Monitor, Uterine Contraction, External (For Use In Clinic)), a Class II device regulated under 21 CFR 884.2720. Tokos Medical Corp. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 3, 1989
- Date Received
- May 22, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Uterine Contraction, External (For Use In Clinic)
- Device Class
- Class II
- Regulation Number
- 884.2720
- Review Panel
- OB
- Submission Type