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FDA 510(k)

PVC AND SILICONE MANUAL RESUSCITATORS

K-Number: K051177 · 2005-08-29

ApplicantDavid Medical Products Co.,Ltd
Decision Date2005-08-29
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PVC AND SILICONE MANUAL RESUSCITATORS is the device name listed in this FDA 510(k) record. The listed applicant is David Medical Products Co.,Ltd. It received FDA 510(k) clearance on 2005-08-29 under 510(k) number K051177. The device is classified under product code BTM. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PVC AND SILICONE MANUAL RESUSCITATORS?

PVC AND SILICONE MANUAL RESUSCITATORS is a medical device that received FDA 510(k) clearance on 2005-08-29. The listed applicant is David Medical Products Co.,Ltd. The 510(k) number is K051177.

When did PVC AND SILICONE MANUAL RESUSCITATORS receive FDA 510(k) clearance?

PVC AND SILICONE MANUAL RESUSCITATORS received FDA 510(k) clearance on 2005-08-29, under 510(k) number K051177.

Who is the listed applicant for PVC AND SILICONE MANUAL RESUSCITATORS?

The FDA 510(k) record lists David Medical Products Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PVC AND SILICONE MANUAL RESUSCITATORS?

The FDA product code for PVC AND SILICONE MANUAL RESUSCITATORS is BTM.

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Related Devices (Code: BTM)

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.

K251631The BAG manual resuscitator and accessoriesLaerdal Medical ASK243861butterflyBVMCompact Medical, Inc.K221841EOlife®ArcheonK212905Sotair DeviceSafe Bvm CorporationK210288Disposable Manual ResuscitatorXiamen Compower Medical Tech. Co., Ltd.K181583Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20Flexicare Medical Limited.

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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