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

METABOLIC SYSTEMS

K Number: K894154 · Decision Oct 24, 1989
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
60
Applicant Total
9
Review Days
132

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Basic Information

Device Name
METABOLIC SYSTEMS
K Number
K894154
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
890.5360
Medical Specialty
Physical Medicine
Decision
Substantially Equivalent
Applicant
Cybex
Date Received
June 14, 1989
Decision Date
October 24, 1989
Product Code
ISD
Advisory Committee
Physical Medicine
Review Advisory Committee
PM
Third Party
N

Classifications

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

Product Code Device Name
ISD Exerciser, Measuring

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K872911 CYBEX 340
K844368 LINEAR LIFT DEVICE
K843739 CYBEX TORSO TESTING & REHABILITATION