510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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MAAClass II

Monitor, Fetal Doppler Ultrasound

21 CFR 884.2660 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

MAA is the FDA product code for Monitor, Fetal Doppler Ultrasound, a class II device type, regulated under 21 CFR 884.2660. As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
MAA
Device name
Monitor, Fetal Doppler Ultrasound
Regulation
21 CFR 884.2660
Device class
Class II
Review panel
Obstetrics/Gynecology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
9
Ingested recalls
3

Clearances, product code MAA

By decision year
9 clearances under product code MAA with a decision year between 1990 and 2010, 1991 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code MAA by decision year
YearClearances
19902
19913
19922
20091
20101

Applicants with the most clearances

Product code MAA
Applicants holding the most 510(k) clearances under product code MAA
ApplicantClearances
Acuson Corp.3
Edan Instruments, Inc.1
GE Healthcare1
Oxford Medilog, Inc.1
Quantum Medical Systems, Inc.1
Summit Doppler Systems, Inc.1
Toshiba America Medical Systems, In.C1

Companies listing this code with FDA

Companies whose registered establishments list this code