Home / 510(k) Clearances / K090499

510(k) K090499

LIFEDOP MODEL, L350R by Summit Doppler Systems, Inc. — Product Code MAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 2009
Date Received
February 25, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by Summit Doppler Systems, Inc.

  • K103693 — VANTAGE ABI (February 15, 2011)
  • K101816 — STN PROBE (August 19, 2010)
  • K093393 — LIFEDOP MODEL 300ABI (December 24, 2009)
  • K063600 — VISTA AVS (December 19, 2006)
  • K060410 — ECHOHEART TRANSVAGINAL DOPPLER PROBE (April 10, 2006)
  • K024197 — LIFEDOP DOPPLER (January 3, 2003)

Other clearances for product code MAA

  • K102138 — ULTRASONIC TABLETOP DOPPLER; ULTRASONIC TABLETOP DOPPLER (October 28, 2010)
  • 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)
  • K894992 — QUANTUM QAD ANGIODYNOGRAPH ULTRASOUND SYSTEM (February 23, 1990)