Product code MAA— Obstetrics/Gynecology

FDA has cleared 9 devices under product code MAA between 1990 and 2010, filed by 7 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20101 clearance
• 20091 clearance
• 19922 clearances
• 19913 clearances
• 19902 clearances

• Acuson Corp.3 clearances
• Toshiba America Medical Systems, In.C1 clearance
• Summit Doppler Systems, Inc.1 clearance
• Quantum Medical Systems, Inc.1 clearance
• Oxford Medilog, Inc.1 clearance
• GE Medical Systems1 clearance
• Edan Instruments, Inc.1 clearance

• K102138 — ULTRASONIC TABLETOP DOPPLER; ULTRASONIC TABLETOP DOPPLEREdan Instruments, Inc.·2010-10-28
• K090499 — LIFEDOP MODEL, L350RSummit Doppler Systems, Inc.·2009-03-31
• K915138 — GE SONOCHROMEGE Medical Systems·1992-10-20
• K905536 — FETAL DOPPLERToshiba America Medical Systems, In.C·1992-04-21
• K904600 — L582 TRANSDUCERAcuson Corp.·1991-06-24
• K905456 — L328 TRANSDUCERAcuson Corp.·1991-05-28
• K904951 — S5192R TRANSDUCERAcuson Corp.·1991-04-29
• K895909 — SONICAID MODEL VASOFLO 4Oxford Medilog, Inc.·1990-07-09
• K894992 — QUANTUM QAD ANGIODYNOGRAPH ULTRASOUND SYSTEMQuantum Medical Systems, Inc.·1990-02-23