510(k) K955887
K955887 is an FDA 510(k) premarket notification submitted by Newmed Corp. for the device "NEWMED ABP-LITE". The FDA issued a decision of Substantially Equivalent on September 5, 1996. The device falls under product code DXW (System, Phonocatheter, Intracavitary), a Class II device regulated under 21 CFR 870.1270. Newmed Corp. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 5, 1996
- Date Received
- December 28, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Phonocatheter, Intracavitary
- Device Class
- Class II
- Regulation Number
- 870.1270
- Review Panel
- CV
- Submission Type