FDA 510(k) FDA class 2 Unknown 🇺🇸 United States

I.V. START KITS

K Number: K875315 · Decision Feb 17, 1988
Classifications
1
FEI Numbers
68
Registration Numbers
68
Same Product Code
29
Applicant Total
3
Review Days
50

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
I.V. START KITS
K Number
K875315
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
880.5200
Medical Specialty
General Hospital
Decision
Unknown
Applicant
Ni-Med, Inc.
Date Received
December 29, 1987
Decision Date
February 17, 1988
Product Code
LRS
Advisory Committee
General Hospital
Review Advisory Committee
SU
Third Party
N

Classifications

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

Product Code Device Name
LRS I.V. Start Kit

Similar 510(k) Clearances

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

View all

Other Clearances by Ni-Med, Inc.

K Number Device Name
K981910 SUCTION CATHETER
K872824 P. URINE METER, 250CC