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

MESAMIV RECORDER

K Number: K901466 · Decision Jun 8, 1990
Classifications
1
FEI Numbers
106
Registration Numbers
106
Same Product Code
171
Applicant Total
2
Review Days
72

Basic Information

Device Name
MESAMIV RECORDER
K Number
K901466
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
868.2375
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Applicant
MADAUS MEDTEC, INC.
Date Received
March 28, 1990
Decision Date
June 8, 1990
Product Code
BZQ
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
BZQ Monitor, Breathing Frequency

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (BZQ), ordered by most recent decision date.

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Other Clearances by MADAUS MEDTEC, INC.

K Number Device Name
K894641 MESAM RECORDER