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

NON-INVASIVE CLINICAL VASCULAR LAB

K Number: K832679 · Decision Jan 3, 1984
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
17
Applicant Total
12
Review Days
147

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Basic Information

Device Name
NON-INVASIVE CLINICAL VASCULAR LAB
K Number
K832679
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
870.2390
Medical Specialty
Cardiovascular
Decision
Substantially Equivalent
Applicant
Life Sciences Manufacturing, Inc.
Date Received
August 9, 1983
Decision Date
January 3, 1984
Product Code
DQC
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
DQC Phonocardiograph

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Other Clearances by Life Sciences Manufacturing, Inc.

K Number Device Name
K910905 SFA-II MICROPROCESSOR-CONTROLLED MODULE
K903700 IPG-II MODULE
K900365 PAG MICROPROCESSOR-CONTROLLED MODULE
K896500 CWD/PPG MODULE
K895588 PORTABLE AIR PLETHYSMOGRAPH
K896528 SFA MODULE
K884624 MVL/MODULAB WITH PVR MODULE
K873041 A-V RECORDER
K822522 CUTANEOUS PRESSURE PLETHYSMOGRAPH
K811560 AUTOMATED PHYSIOLOGIC PROFILE MONITOR
Search all 12 clearances from Life Sciences Manufacturing, Inc. →