510(k) K843448
K843448 is an FDA 510(k) premarket notification submitted by Scimed Life Systems, Inc. for the device "SCIMED PM200 INFLATION MANOMETER". The FDA issued a decision of Substantially Equivalent on Oct 23, 1984. The device falls under product code MAV (Syringe, Balloon Inflation), a Class II device regulated under 21 CFR 870.1650. Scimed Life Systems, Inc. has 108 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 23, 1984
- Date Received
- Sep 5, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Syringe, Balloon Inflation
- Device Class
- Class II
- Regulation Number
- 870.1650
- Review Panel
- CV
- Submission Type
- 510(k)