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

PRESSURE INFUSOR #1900

K Number: K860084 · Decision Mar 18, 1986
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
34
Applicant Total
5
Review Days
68

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Basic Information

Device Name
PRESSURE INFUSOR #1900
K Number
K860084
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
880.5420
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Applicant
Pa Medical Corp.
Date Received
January 9, 1986
Decision Date
March 18, 1986
Product Code
KZD
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
KZD Infusor, Pressure, For I.V. Bags

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Other Clearances by Pa Medical Corp.

K Number Device Name
K910903 INFLATE-A-CUFF #7014
K871449 ONCOLOGY SPT SYS #MS-C10 MEDICATION RESERVOIR BAG
K854595 P.A. MEDICAL VAGINAL IRRIGATION SET #1130
K853309 P.A. ENTERAL FEEDING BAG 1100