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

NEWPORT C250 AIR COMPRESSOR MODEL C250

K Number: K041406 · Decision Dec 15, 2004
Classifications
1
FEI Numbers
72
Registration Numbers
72
Same Product Code
73
Applicant Total
1
Review Days
203

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
NEWPORT C250 AIR COMPRESSOR MODEL C250
K Number
K041406
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
868.6250
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Newport Medical Instruments
Date Received
May 26, 2004
Decision Date
December 15, 2004
Product Code
BTI
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
BTI Compressor, Air, Portable

Similar 510(k) Clearances

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

View all