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510(k) K894992

QUANTUM QAD ANGIODYNOGRAPH ULTRASOUND SYSTEM by Quantum Medical Systems, Inc. — Product Code MAA

K894992 is an FDA 510(k) premarket notification submitted by Quantum Medical Systems, Inc. for the device "QUANTUM QAD ANGIODYNOGRAPH ULTRASOUND SYSTEM". The FDA issued a decision of Substantially Equivalent on February 23, 1990. The device falls under product code MAA (Monitor, Fetal Doppler Ultrasound), a Class II device regulated under 21 CFR 884.2660. Quantum Medical Systems, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 1990
Date Received
August 8, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Fetal Doppler Ultrasound
Device Class
Class II
Regulation Number
884.2660
Review Panel
RA
Submission Type

Other clearances by Quantum Medical Systems, Inc.

  • K904019 — QUANTUM 2000 ANGIODYNOGRAPH ULTRASOUND SYSTEM (March 22, 1991)
  • K890998 — QAD ANGIODYNOGRAPH ULTRASOUND: COLOR DOPPLER EVAL. (May 2, 1989)
  • K860581 — QAD-1 ANGIODYNOGRAPH ULTRASOUND SYSTEM (February 13, 1987)
  • K853217 — QAD-1 ANGIO DYNOGRAPH ULTRASO W/5.0 7.5 MHZ PROBES (December 30, 1985)

Other clearances for product code MAA

  • K102138 — ULTRASONIC TABLETOP DOPPLER; ULTRASONIC TABLETOP DOPPLER (October 28, 2010)
  • K090499 — LIFEDOP MODEL, L350R (March 31, 2009)
  • K915138 — GE SONOCHROME (October 20, 1992)
  • K905536 — FETAL DOPPLER (April 21, 1992)
  • K904600 — L582 TRANSDUCER (June 24, 1991)
  • K905456 — L328 TRANSDUCER (May 28, 1991)
  • K904951 — S5192R TRANSDUCER (April 29, 1991)
  • K895909 — SONICAID MODEL VASOFLO 4 (July 9, 1990)

FDA data resources