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FDA 510(k)

INSPIREASE

K-Number: K832037 · 1983-08-16

ApplicantKey Pharmaceuticals, Inc.
Decision Date1983-08-16
Product CodeCCQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

INSPIREASE is the device name listed in this FDA 510(k) record. The listed applicant is Key Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 1983-08-16 under 510(k) number K832037. 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 INSPIREASE?

INSPIREASE is a medical device that received FDA 510(k) clearance on 1983-08-16. The listed applicant is Key Pharmaceuticals, Inc.. The 510(k) number is K832037.

When did INSPIREASE receive FDA 510(k) clearance?

INSPIREASE received FDA 510(k) clearance on 1983-08-16, under 510(k) number K832037.

Who is the listed applicant for INSPIREASE?

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

What is the FDA product code for INSPIREASE?

The FDA product code for INSPIREASE is CCQ.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Key Pharmaceuticals, 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.

K873793INSPIREASE(R), DRUG DELIVERY SYSTEM

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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