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FDA 510(k)

PINWHEEL

K-Number: K780422 · 1978-04-04

ApplicantProjects IN Health
Decision Date1978-04-04
Product CodeGWY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PINWHEEL is the device name listed in this FDA 510(k) record. The listed applicant is Projects IN Health. It received FDA 510(k) clearance on 1978-04-04 under 510(k) number K780422. The device is classified under product code GWY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PINWHEEL?

PINWHEEL is a medical device that received FDA 510(k) clearance on 1978-04-04. The listed applicant is Projects IN Health. The 510(k) number is K780422.

When did PINWHEEL receive FDA 510(k) clearance?

PINWHEEL received FDA 510(k) clearance on 1978-04-04, under 510(k) number K780422.

Who is the listed applicant for PINWHEEL?

The FDA 510(k) record lists Projects IN Health as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PINWHEEL?

The FDA product code for PINWHEEL is GWY.

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 Projects IN Health 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.

K781224METER, FLOW, PEAKK770580PEAK FLOW METER

Related Devices (Code: GWY)

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.

K050313BIS SRS (SEMI-RESUABLE SENSOR)Aspect Medical Systems, Inc.K942926NEURO-AIDEBurke Neutech, Inc.K871167SENSITESTERDexin Pty. , Ltd.K8517491-380 PINWHEEL (WARTENBERG)Artiberia

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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