FDA 510(k) FDA class 1 Unknown 🇺🇸 United States

NEOLINE(TM)

K Number: K914778 · Decision Sep 16, 1992
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
57
Applicant Total
7
Review Days
329

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Basic Information

Device Name
NEOLINE(TM)
K Number
K914778
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
868.1100
Medical Specialty
Anesthesiology
Decision
Unknown
Statement or Summary
Statement
Applicant
Martech Medical Products, Inc.
Date Received
October 23, 1991
Decision Date
September 16, 1992
Product Code
CBT
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
CBT Arterial Blood Sampling Kit

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Other Clearances by Martech Medical Products, Inc.

K Number Device Name
K960519 MARTECH ENDOSCOPIC INJECTION NEEDLE
K931924 MARKSMAN ARTERIAL BLOOD GAS SYRINGE
K922438 PRO2 OXYGEN ANALYZER
K926007 ACCESSORY TO PISTON SYRINGE
K910970 MARKSMAN ARTERIAL BLOOD GAS SYRINGE
K890473 NEEDLE GUARD(TM)