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

LIGHT REFLECTION RHEOGRAPHY

K Number: K833561 · Decision Jan 8, 1985
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
52
Applicant Total
1
Review Days
454

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Basic Information

Device Name
LIGHT REFLECTION RHEOGRAPHY
K Number
K833561
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
870.2780
Medical Specialty
Cardiovascular
Decision
Substantially Equivalent
Applicant
Instru-Med, Inc.
Date Received
October 12, 1983
Decision Date
January 8, 1985
Product Code
JOM
Advisory Committee
Cardiovascular
Review Advisory Committee
CV
Third Party
N

Classifications

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

Product Code Device Name
JOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic

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