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

X-RAY APRON

K Number: K870563 · Decision Feb 19, 1987
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
5
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
X-RAY APRON
K Number
K870563
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
892.6500
Medical Specialty
Radiology
Decision
Substantially Equivalent
Applicant
X-Tech, Ltd.
Date Received
February 10, 1987
Decision Date
February 19, 1987
Product Code
EAJ
Advisory Committee
Radiology
Review Advisory Committee
RA
Third Party
N

Classifications

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

Product Code Device Name
EAJ Apron, Leaded

Similar 510(k) Clearances

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

View all