510(k) K901084
K901084 is an FDA 510(k) premarket notification submitted by Healthdyne Cardiovascular, Inc. for the device "ISOFLO INTRAUTERINE PRESSURE MONITORING & AMNIO.". The FDA issued a decision of Substantially Equivalent on June 1, 1990. The device falls under product code KXO (Monitor, Pressure, Intrauterine), a Class II device regulated under 21 CFR 884.2700. Healthdyne Cardiovascular, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 1, 1990
- Date Received
- March 7, 1990
- 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