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FDA 510(k)

DAD 16S, DATA ACQUISTION DEVICE 16 CH. SERIES

K-Number: K883461 · 1988-11-30

ApplicantBiohm, Inc.
Decision Date1988-11-30
Product CodeGYE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DAD 16S, DATA ACQUISTION DEVICE 16 CH. SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Biohm, Inc.. It received FDA 510(k) clearance on 1988-11-30 under 510(k) number K883461. The device is classified under product code GYE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DAD 16S, DATA ACQUISTION DEVICE 16 CH. SERIES?

DAD 16S, DATA ACQUISTION DEVICE 16 CH. SERIES is a medical device that received FDA 510(k) clearance on 1988-11-30. The listed applicant is Biohm, Inc.. The 510(k) number is K883461.

When did DAD 16S, DATA ACQUISTION DEVICE 16 CH. SERIES receive FDA 510(k) clearance?

DAD 16S, DATA ACQUISTION DEVICE 16 CH. SERIES received FDA 510(k) clearance on 1988-11-30, under 510(k) number K883461.

Who is the listed applicant for DAD 16S, DATA ACQUISTION DEVICE 16 CH. SERIES?

The FDA 510(k) record lists Biohm, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DAD 16S, DATA ACQUISTION DEVICE 16 CH. SERIES?

The FDA product code for DAD 16S, DATA ACQUISTION DEVICE 16 CH. SERIES is GYE.

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Related Devices (Code: GYE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K963195WIRELESS EEG RECORDING SYSTEM MODEL W32Cme Telemetrix, Inc.K970659DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVERTelediagnostic Systems, Inc.K895895MODEL 219 TELEMETRY SYSTEMMennen Medical, Inc.K891405BMS-2000 MOBILE EEG SYSTEMBuckman Co., Inc.K885328RS-10 TELEPHONIC POLYSOMNOGRAPHY RECEIVERTelediagnostic Systems, Inc.K883947ISO-100 ISOLATION AMPLIFIERTelediagnostic Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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