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FDA 510(k)

LUNG EXER. BAG, POST-OP, MODIFIED

K-Number: K781245 · 1978-09-20

ApplicantDytek Corp.
Decision Date1978-09-20
Product CodeBWF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

LUNG EXER. BAG, POST-OP, MODIFIED is the device name listed in this FDA 510(k) record. The listed applicant is Dytek Corp.. It received FDA 510(k) clearance on 1978-09-20 under 510(k) number K781245. The device is classified under product code BWF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUNG EXER. BAG, POST-OP, MODIFIED?

LUNG EXER. BAG, POST-OP, MODIFIED is a medical device that received FDA 510(k) clearance on 1978-09-20. The listed applicant is Dytek Corp.. The 510(k) number is K781245.

When did LUNG EXER. BAG, POST-OP, MODIFIED receive FDA 510(k) clearance?

LUNG EXER. BAG, POST-OP, MODIFIED received FDA 510(k) clearance on 1978-09-20, under 510(k) number K781245.

Who is the listed applicant for LUNG EXER. BAG, POST-OP, MODIFIED?

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

What is the FDA product code for LUNG EXER. BAG, POST-OP, MODIFIED?

The FDA product code for LUNG EXER. BAG, POST-OP, MODIFIED is BWF.

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 Dytek 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.

K760168PENCIL, ELECTROSURGICALK760167BAG, POST OPERATIVE LUNG EXERCIZING BLOW

Related Devices (Code: BWF)

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.

K241152InSeeTidal Medical Technologies, LLCK233855AllPEPEnchant Tek Co. , Ltd.K221058LungTrainer (MD2 & MD3)Lung Trainers, LLCK222018Breathe+Peep Medical, LLC Dba Go2 DevicesK220565Hudson RCI Triflo II Incentive Deep Breathing ExerciserMedline Industries, Inc.K203378PulsehalerRespinova, Ltd.

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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