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

MEDTECH C.P.R. MASK

K Number: K862199 · Decision Jun 13, 1986
Classifications
1
FEI Numbers
229
Registration Numbers
229
Same Product Code
56
Applicant Total
2
Review Days
3

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Basic Information

Device Name
MEDTECH C.P.R. MASK
K Number
K862199
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
868.5110
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Applicant
The Medtech Group, Inc.
Date Received
June 10, 1986
Decision Date
June 13, 1986
Product Code
CAE
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
CAE Airway, Oropharyngeal, Anesthesiology

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Other Clearances by The Medtech Group, Inc.

K Number Device Name
K895203 EN-TRAP SYRINGE