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FDA 510(k)

INFANT PERCUSSOR PA-010

K-Number: K842608 · 1984-07-23

ApplicantAlpha Medical Systems
Decision Date1984-07-23
Product CodeBYI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

INFANT PERCUSSOR PA-010 is the device name listed in this FDA 510(k) record. The listed applicant is Alpha Medical Systems. It received FDA 510(k) clearance on 1984-07-23 under 510(k) number K842608. The device is classified under product code BYI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFANT PERCUSSOR PA-010?

INFANT PERCUSSOR PA-010 is a medical device that received FDA 510(k) clearance on 1984-07-23. The listed applicant is Alpha Medical Systems. The 510(k) number is K842608.

When did INFANT PERCUSSOR PA-010 receive FDA 510(k) clearance?

INFANT PERCUSSOR PA-010 received FDA 510(k) clearance on 1984-07-23, under 510(k) number K842608.

Who is the listed applicant for INFANT PERCUSSOR PA-010?

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

What is the FDA product code for INFANT PERCUSSOR PA-010?

The FDA product code for INFANT PERCUSSOR PA-010 is BYI.

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 Alpha Medical Systems 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.

K842607INFANT APNEA BED STIMULATOR AA-010

Related Devices (Code: BYI)

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.

K252849AffloVest® Mobile Airway Clearance TherapyTactile MedicalK250860BreatheBand® (Model 1000)Exemplar Medical, LLCK242063LibAirty Airway Clearance SystemSynchrony Medical , Ltd.K240959Respiratory Muscle TrainerChongqing Moffy Innovation Technology Co., Ltd.K233441The Vest APX System (PVAPX1)Baxter Healthcare CorportationK222496Electromed SmartVest Airway Clearance SystemElectromed, Inc.

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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