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

DEVETHERM

K Number: K822873 · Decision Mar 24, 1983
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
2
Applicant Total
2
Review Days
178

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Basic Information

Device Name
DEVETHERM
K Number
K822873
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
870.2750
Medical Specialty
Cardiovascular
Decision
Substantially Equivalent
Applicant
Eko Scann AB
Date Received
September 27, 1982
Decision Date
March 24, 1983
Product Code
DQB
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
DQB Phlebograph, Impedance

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Other Clearances by Eko Scann AB

K Number Device Name
K822823 HEMATOLOGY COMPUTER-INTERFACE, VISCOUNT