FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

WRIGHT POCKET DOPPLERS VASCULAR & OBSTETRIC

K Number: K901015 · Decision Nov 5, 1990
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
136
Applicant Total
3
Review Days
245

Research this 510(k) in seconds

The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

Free to try · every answer cites its records

Basic Information

Device Name
WRIGHT POCKET DOPPLERS VASCULAR & OBSTETRIC
K Number
K901015
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
870.2100
Medical Specialty
Cardiovascular
Decision
Substantially Equivalent
Applicant
Wright Medical Corp.
Date Received
March 5, 1990
Decision Date
November 5, 1990
Product Code
DPW
Advisory Committee
Cardiovascular
Review Advisory Committee
CV
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
DPW Flowmeter, Blood, Cardiovascular

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (DPW), ordered by most recent decision date.

View all

Other Clearances by Wright Medical Corp.

K Number Device Name
K905129 BAERVELDT GLAUCOMA IMPLANT
K892501 WRIGHT MEDICAL FETASAFE