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

META III

K Number: K790300 · Decision Mar 27, 1979
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
574
Applicant Total
3
Review Days
43

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Basic Information

Device Name
META III
K Number
K790300
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
870.2340
Medical Specialty
Cardiovascular
Decision
Substantially Equivalent
Applicant
Hittman Medical Systems
Date Received
February 12, 1979
Decision Date
March 27, 1979
Product Code
DPS
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
DPS Electrocardiograph

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K Number Device Name
K832772 SATURN-24HR. HOLTER SCANNER
K791632 COMPU-SCAN