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FDA 510(k)

DECITEL AUSCULSCOPE

K-Number: K860994 · 1986-11-07

ApplicantBloomfield Research and Development, Inc.
Decision Date1986-11-07
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DECITEL AUSCULSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Bloomfield Research and Development, Inc.. It received FDA 510(k) clearance on 1986-11-07 under 510(k) number K860994. The device is classified under product code DQD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DECITEL AUSCULSCOPE?

DECITEL AUSCULSCOPE is a medical device that received FDA 510(k) clearance on 1986-11-07. The listed applicant is Bloomfield Research and Development, Inc.. The 510(k) number is K860994.

When did DECITEL AUSCULSCOPE receive FDA 510(k) clearance?

DECITEL AUSCULSCOPE received FDA 510(k) clearance on 1986-11-07, under 510(k) number K860994.

Who is the listed applicant for DECITEL AUSCULSCOPE?

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

What is the FDA product code for DECITEL AUSCULSCOPE?

The FDA product code for DECITEL AUSCULSCOPE is DQD.

Related Clinical Trials

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Other records listing Bloomfield Research and Development, 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.

K860992VOX COMPANIONK860993P.O. VOX

Related Devices (Code: DQD)

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.

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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.

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