Home / 510(k) Clearances / K050313

510(k) K050313

BIS SRS (SEMI-RESUABLE SENSOR) by Aspect Medical Systems, Inc. — Product Code GWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 2005
Date Received
February 9, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Pinwheel
Device Class
Class I
Regulation Number
882.1750
Review Panel
NE
Submission Type

Other clearances by Aspect Medical Systems, Inc.

  • K093183 — BIS QUATRO SENSOR (October 23, 2009)
  • K091854 — BIS CLICK SENSOR/CABLE (July 2, 2009)
  • K072286 — BIS EEG VISTA MONITOR SYSTEM AND BISX (November 20, 2007)
  • K062613 — BIS EEG MONITOR VIEW (June 18, 2007)
  • K070069 — ZIPPREP ELECTRODE (February 5, 2007)
  • K062692 — BIS BILATERAL SENSOR (December 13, 2006)
  • K052981 — BIS EEG MONITOR, MODEL BISX4 (November 1, 2005)
  • K052362 — BIS EEG MONITOR, MODEL A-3000 (September 9, 2005)
  • K041670 — BIS PEDIATRIC SENSOR (July 6, 2004)
  • K040183 — BISX (February 25, 2004)

Other clearances for product code GWY

  • K942926 — NEURO-AIDE (August 3, 1994)
  • K871167 — SENSITESTER (April 1, 1987)
  • K851749 — 1-380 PINWHEEL (WARTENBERG) (June 13, 1985)
  • K780422 — PINWHEEL (April 4, 1978)