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FDA 510(k)

BIO-LOG 8+1 AMBULATORY PHYSIOLOGIC RECORDER

K-Number: K864928 · 1987-03-31

ApplicantBio-Scan, Inc.
Decision Date1987-03-31
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BIO-LOG 8+1 AMBULATORY PHYSIOLOGIC RECORDER is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Scan, Inc.. It received FDA 510(k) clearance on 1987-03-31 under 510(k) number K864928. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIO-LOG 8+1 AMBULATORY PHYSIOLOGIC RECORDER?

BIO-LOG 8+1 AMBULATORY PHYSIOLOGIC RECORDER is a medical device that received FDA 510(k) clearance on 1987-03-31. The listed applicant is Bio-Scan, Inc.. The 510(k) number is K864928.

When did BIO-LOG 8+1 AMBULATORY PHYSIOLOGIC RECORDER receive FDA 510(k) clearance?

BIO-LOG 8+1 AMBULATORY PHYSIOLOGIC RECORDER received FDA 510(k) clearance on 1987-03-31, under 510(k) number K864928.

Who is the listed applicant for BIO-LOG 8+1 AMBULATORY PHYSIOLOGIC RECORDER?

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

What is the FDA product code for BIO-LOG 8+1 AMBULATORY PHYSIOLOGIC RECORDER?

The FDA product code for BIO-LOG 8+1 AMBULATORY PHYSIOLOGIC RECORDER is GWQ.

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Other records listing Bio-Scan, Inc. as applicant

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.

K003480BIOFINDK925735EEG ANALYZERK841685EEG ELECTRODESK841683Q.P. PREAMPLIFIER SYSK841684BIO/SCAN BIOLOG CASSETTE RECORDER

Related Devices (Code: GWQ)

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.

K261604Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)Neuroelectrics Barcelona S.L.U.K260455New Wave SystemZeto, Inc.K233403Flexset SystemZeto, Inc.K231366Neuronaute PlusBioserenity SasK221959Q21Neurofield, Inc.K231457SPARK ScanSpark Neuro, Inc.

Official Source

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

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