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

TRANSPORTABLE OXYGEN PURITY ANALYZER

K Number: K780448 · Decision Apr 19, 1978
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
120
Applicant Total
2
Review Days
30

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Basic Information

Device Name
TRANSPORTABLE OXYGEN PURITY ANALYZER
K Number
K780448
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
868.1720
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Applicant
Taylor Instrument Analytics Co.
Date Received
March 20, 1978
Decision Date
April 19, 1978
Product Code
CCL
Advisory Committee
Anesthesiology
Review Advisory Committee
AN
Third Party
N

Classifications

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

Product Code Device Name
CCL Analyzer, Gas, Oxygen, Gaseous-Phase

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K Number Device Name
K760972 TYCOS DIAGNOSTIC PENLIGHT