FDA 510(k)

BECHLER MEDICAL, MODEL 5000,THE WIZ HOLTER SCANNER

K-Number: K861240 · 1986-05-02

Decision Date1986-05-02

Product CodeDSI

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

BECHLER MEDICAL, MODEL 5000,THE WIZ HOLTER SCANNER is the device name listed in this FDA 510(k) record. The listed applicant is Mountain View Medical. It received FDA 510(k) clearance on 1986-05-02 under 510(k) number K861240. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BECHLER MEDICAL, MODEL 5000,THE WIZ HOLTER SCANNER?

BECHLER MEDICAL, MODEL 5000,THE WIZ HOLTER SCANNER is a medical device that received FDA 510(k) clearance on 1986-05-02. The listed applicant is Mountain View Medical. The 510(k) number is K861240.

When did BECHLER MEDICAL, MODEL 5000,THE WIZ HOLTER SCANNER receive FDA 510(k) clearance?

BECHLER MEDICAL, MODEL 5000,THE WIZ HOLTER SCANNER received FDA 510(k) clearance on 1986-05-02, under 510(k) number K861240.

Who is the listed applicant for BECHLER MEDICAL, MODEL 5000,THE WIZ HOLTER SCANNER?

The FDA 510(k) record lists Mountain View Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BECHLER MEDICAL, MODEL 5000,THE WIZ HOLTER SCANNER?

The FDA product code for BECHLER MEDICAL, MODEL 5000,THE WIZ HOLTER SCANNER is DSI.

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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.