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510(k) K895909

SONICAID MODEL VASOFLO 4 by Oxford Medilog, Inc. — Product Code MAA

K895909 is an FDA 510(k) premarket notification submitted by Oxford Medilog, Inc. for the device "SONICAID MODEL VASOFLO 4". The FDA issued a decision of Substantially Equivalent on July 9, 1990. The device falls under product code MAA (Monitor, Fetal Doppler Ultrasound), a Class II device regulated under 21 CFR 884.2660. Oxford Medilog, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 1990
Date Received
October 10, 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 Oxford Medilog, Inc.

  • K923737 — MODEL MEDILOG RAPIDE (January 5, 1994)
  • K920295 — MEDILOG EXCEL ECG ANALYSIS SYSTEM (MODIFIED) (August 18, 1992)
  • K912890 — MODEL SONICAID AXIS (January 9, 1992)
  • K912639 — SONICAID TEAM (December 31, 1991)
  • K904763 — MENTOR EEG SYSTEM (April 10, 1991)
  • K902690 — SONICAID MODEL MERIDIAN 800 (February 5, 1991)
  • K896535 — MEDILOG OPTIMA (January 18, 1990)
  • K891383 — MEDILOG 9200 EEG REPLAY/ANALYSIS SYSTEM (June 1, 1989)
  • K890330 — MEDILOG 6000-FD REPORT GENERATOR (April 20, 1989)
  • K890338 — MEDILOG EDITOR (April 19, 1989)

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)
  • K894992 — QUANTUM QAD ANGIODYNOGRAPH ULTRASOUND SYSTEM (February 23, 1990)

FDA data resources