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FDA 510(k)

PNEUMO PULSSOR III

K-Number: K821570 · 1982-06-03

ApplicantStrom Corp.
Decision Date1982-06-03
Product CodeBYI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PNEUMO PULSSOR III is the device name listed in this FDA 510(k) record. The listed applicant is Strom Corp.. It received FDA 510(k) clearance on 1982-06-03 under 510(k) number K821570. 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 PNEUMO PULSSOR III?

PNEUMO PULSSOR III is a medical device that received FDA 510(k) clearance on 1982-06-03. The listed applicant is Strom Corp.. The 510(k) number is K821570.

When did PNEUMO PULSSOR III receive FDA 510(k) clearance?

PNEUMO PULSSOR III received FDA 510(k) clearance on 1982-06-03, under 510(k) number K821570.

Who is the listed applicant for PNEUMO PULSSOR III?

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 PNEUMO PULSSOR III?

The FDA product code for PNEUMO PULSSOR III 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.

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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.

K821265PNEUMOPULSSOR (PPS II)K813438PNEUMO 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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