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

MULTIMED (TM) PULMONARY FUNCTION TESTING SYSTEM

K Number: K895414 · Decision Feb 12, 1990
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
227
Applicant Total
5
Review Days
164

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
MULTIMED (TM) PULMONARY FUNCTION TESTING SYSTEM
K Number
K895414
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
868.1840
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Applicant
Integrated Medical Systems, Inc.
Date Received
September 1, 1989
Decision Date
February 12, 1990
Product Code
BZG
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
BZG Spirometer, Diagnostic

Similar 510(k) Clearances

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

View all

Other Clearances by Integrated Medical Systems, Inc.

K Number Device Name
K082256 LIFE SUPPORT FOR TRAUMA AND TRNSPORT (LSTAT) G6 LITE
K902682 STICK-GARD STERILE CAP
K871659 IMS-2000S STRESS MONITOR
K870934 IMS-2000R RESTING ELECTROCARDIOGRAPHIC SYSTEM