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FDA 510(k)

PNEUMOPULSSOR (PPS II)

K-Number: K821265 · 1982-07-26

ApplicantStrom Corp.
Decision Date1982-07-26
Product CodeBYI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PNEUMOPULSSOR (PPS II) is the device name listed in this FDA 510(k) record. The listed applicant is Strom Corp.. It received FDA 510(k) clearance on 1982-07-26 under 510(k) number K821265. 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 PNEUMOPULSSOR (PPS II)?

PNEUMOPULSSOR (PPS II) is a medical device that received FDA 510(k) clearance on 1982-07-26. The listed applicant is Strom Corp.. The 510(k) number is K821265.

When did PNEUMOPULSSOR (PPS II) receive FDA 510(k) clearance?

PNEUMOPULSSOR (PPS II) received FDA 510(k) clearance on 1982-07-26, under 510(k) number K821265.

Who is the listed applicant for PNEUMOPULSSOR (PPS II)?

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

What is the FDA product code for PNEUMOPULSSOR (PPS II)?

The FDA product code for PNEUMOPULSSOR (PPS II) 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 Strom Corp. 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.

K821570PNEUMO PULSSOR IIIK813438PNEUMO PULSSOR

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

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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