FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

F4912 NIGHT VISION AID

K Number: K761215 · Decision Dec 16, 1976
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
6
Applicant Total
1
Review Days
9

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
F4912 NIGHT VISION AID
K Number
K761215
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
886.5900
Medical Specialty
Ophthalmic
Decision
Substantially Equivalent
Applicant
Itt Corp.
Date Received
December 7, 1976
Decision Date
December 16, 1976
Product Code
HPG
Advisory Committee
Ophthalmic
Review Advisory Committee
OP
Third Party
N

Classifications

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

Product Code Device Name
HPG Aid, Vision, Electronic, Battery-Powered

Similar 510(k) Clearances

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

View all