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FDA 510(k)

MICRO-INHALER MODEL TV-7000 & TV-8000

K-Number: K851254 · 1985-06-18

ApplicantBioclimatic, Inc.
Decision Date1985-06-18
Product CodeCCQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MICRO-INHALER MODEL TV-7000 & TV-8000 is the device name listed in this FDA 510(k) record. The listed applicant is Bioclimatic, Inc.. It received FDA 510(k) clearance on 1985-06-18 under 510(k) number K851254. The device is classified under product code CCQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICRO-INHALER MODEL TV-7000 & TV-8000?

MICRO-INHALER MODEL TV-7000 & TV-8000 is a medical device that received FDA 510(k) clearance on 1985-06-18. The listed applicant is Bioclimatic, Inc.. The 510(k) number is K851254.

When did MICRO-INHALER MODEL TV-7000 & TV-8000 receive FDA 510(k) clearance?

MICRO-INHALER MODEL TV-7000 & TV-8000 received FDA 510(k) clearance on 1985-06-18, under 510(k) number K851254.

Who is the listed applicant for MICRO-INHALER MODEL TV-7000 & TV-8000?

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

What is the FDA product code for MICRO-INHALER MODEL TV-7000 & TV-8000?

The FDA product code for MICRO-INHALER MODEL TV-7000 & TV-8000 is CCQ.

Related Clinical Trials

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Related Devices (Code: CCQ)

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.

K972397EZ SPRAYIntertex Research, Inc.K964956E-Z SPACER MASK (SMALL)Airpharma, LLCK961894MDI TUTORMdi Tutor, Inc.K961455MEDSHIELD/AEROCHAMBERDiemolding Corp.K960593SMARTMIST ASTHMA MANAGMENT SYSTEM, SMARTMIST, MODEL NUMBER SM-100/SMARTMIST SPIROMETRY AIRWAY, MODEL NUMBER SA-100Aradigm Corp.K922033SALINE SOLUTION- STERILETrinity Laboratories, 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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