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

MODIFIED CPREVIVER

K Number: K871147 · Decision Apr 20, 1987
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
208
Applicant Total
2
Review Days
39

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
MODIFIED CPREVIVER
K Number
K871147
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
868.5915
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Applicant
Augerscope, Inc.
Date Received
March 12, 1987
Decision Date
April 20, 1987
Product Code
BTM
Advisory Committee
Anesthesiology
Review Advisory Committee
AN
Third Party
N

Classifications

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

Product Code Device Name
BTM Ventilator, Emergency, Manual (Resuscitator)

Similar 510(k) Clearances

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

View all

Other Clearances by Augerscope, Inc.

K Number Device Name
K864125 CPREVIVER