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

IRRIGATION PRESSURE MONITOR

K Number: K872544 · Decision Sep 4, 1987
Classifications
1
FEI Numbers
386
Registration Numbers
386
Same Product Code
680
Applicant Total
6
Review Days
67

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Basic Information

Device Name
IRRIGATION PRESSURE MONITOR
K Number
K872544
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
888.1100
Medical Specialty
Orthopedic
Decision
Substantially Equivalent
Applicant
Avec Scientific Design Corp.
Date Received
June 29, 1987
Decision Date
September 4, 1987
Product Code
HRX
Advisory Committee
Orthopedic
Review Advisory Committee
OR
Third Party
N

Classifications

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

Product Code Device Name
HRX Arthroscope

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K Number Device Name
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K871981 BILATERAL CONTINUOUS PASSIVE MOTION DEVICE
K871900 OVER DRAPE LEG HOLDER
K871982 TOURNIQUET PRESSURE REGULATOR