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FDA 510(k)

RUSCH MANUAL RESUSCITATOR BAG

K-Number: K993194 · 2000-03-24

ApplicantRusch, Inc.
Decision Date2000-03-24
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RUSCH MANUAL RESUSCITATOR BAG is the device name listed in this FDA 510(k) record. The listed applicant is Rusch, Inc.. It received FDA 510(k) clearance on 2000-03-24 under 510(k) number K993194. 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 RUSCH MANUAL RESUSCITATOR BAG?

RUSCH MANUAL RESUSCITATOR BAG is a medical device that received FDA 510(k) clearance on 2000-03-24. The listed applicant is Rusch, Inc.. The 510(k) number is K993194.

When did RUSCH MANUAL RESUSCITATOR BAG receive FDA 510(k) clearance?

RUSCH MANUAL RESUSCITATOR BAG received FDA 510(k) clearance on 2000-03-24, under 510(k) number K993194.

Who is the listed applicant for RUSCH MANUAL RESUSCITATOR BAG?

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

What is the FDA product code for RUSCH MANUAL RESUSCITATOR BAG?

The FDA product code for RUSCH MANUAL RESUSCITATOR BAG is BTM.

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Other records listing Rusch, Inc. 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.

K010420RUSCH MMG/O'NEIL CATHETERK993528RUSCH EMERGENCY MASKK980870RUSCH SILICONE FOLEY CATHETERK974419RUSCH SIMPLASTIC COUNCILL TIP CATHETERK963779RUSCH ENTERAL FEEDING TUBEK970021RUSCH SUPRAPUBIC TRAY

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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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