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510(k) K883461

DAD 16S, DATA ACQUISTION DEVICE 16 CH. SERIES by Biohm, Inc. — Product Code GYE

K883461 is an FDA 510(k) premarket notification submitted by Biohm, Inc. for the device "DAD 16S, DATA ACQUISTION DEVICE 16 CH. SERIES". The FDA issued a decision of Substantially Equivalent on November 30, 1988. The device falls under product code GYE (Encephalogram Telemetry System), a Class II device regulated under 21 CFR 882.1855.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 1988
Date Received
August 12, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Encephalogram Telemetry System
Device Class
Class II
Regulation Number
882.1855
Review Panel
NE
Submission Type

Other clearances for product code GYE

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  • K970659 — DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVER (May 16, 1997)
  • K895895 — MODEL 219 TELEMETRY SYSTEM (February 22, 1990)
  • K891405 — BMS-2000 MOBILE EEG SYSTEM (August 2, 1989)
  • K885328 — RS-10 TELEPHONIC POLYSOMNOGRAPHY RECEIVER (March 22, 1989)
  • K883947 — ISO-100 ISOLATION AMPLIFIER (December 5, 1988)
  • K874257 — S-10 TELEPHONIC POLYSOMNOGRAPH (December 11, 1987)
  • K871120 — M10 EEG MONITOR SCOPE (May 1, 1987)
  • K860128 — MODAC-XXXX INTENSIVE MONITORING OF EEG (March 27, 1986)
  • K833236 — TELEPHONE TRANSMITTER T-10 EEG (November 29, 1983)

FDA data resources