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

PORTAGAS AERATOR

K Number: K761341 · Decision Feb 28, 1977
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
7
Applicant Total
19
Review Days
62

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
PORTAGAS AERATOR
K Number
K761341
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
880.6100
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Applicant
Amsco Co.
Date Received
December 28, 1976
Decision Date
February 28, 1977
Product Code
FLI
Advisory Committee
General Hospital
Review Advisory Committee
HO
Third Party
N

Classifications

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

Product Code Device Name
FLI Cabinet, Ethylene-Oxide Gas Aerator

Similar 510(k) Clearances

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

View all

Other Clearances by Amsco Co.

K Number Device Name
K912471 EAGLE 3000 SDS
K854922 AMSCO POLARIS SL
K833187 HALL OSTEON
K832945 EAGLE 2000 STERILIZER SERIES GAS/AERA
K832188 HALL RECIPROCATOR
K832187 HALL OSCILLATOR
K831086 CEILING MOUNTED SUPPORT
K832186 HALL DRILL/REAMER
K831309 DELIVERY 4 TABLE
K823360 SURGICAL LIGHT
Search all 19 clearances from Amsco Co. →