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510(k) K050313

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

K050313 is an FDA 510(k) premarket notification submitted by Aspect Medical Systems, Inc. for the device "BIS SRS (SEMI-RESUABLE SENSOR)". The FDA issued a decision of Substantially Equivalent on February 24, 2005. The device falls under product code GWY (Pinwheel), a Class I device regulated under 21 CFR 882.1750. Aspect Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

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)

FDA data resources