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FDA 510(k)

RONDEX MASKS MODELS 9015/9011/901102 MODIFIED

K-Number: K914196 · 1991-11-08

ApplicantRondex Products, Inc.
Decision Date1991-11-08
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RONDEX MASKS MODELS 9015/9011/901102 MODIFIED is the device name listed in this FDA 510(k) record. The listed applicant is Rondex Products, Inc.. It received FDA 510(k) clearance on 1991-11-08 under 510(k) number K914196. 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 RONDEX MASKS MODELS 9015/9011/901102 MODIFIED?

RONDEX MASKS MODELS 9015/9011/901102 MODIFIED is a medical device that received FDA 510(k) clearance on 1991-11-08. The listed applicant is Rondex Products, Inc.. The 510(k) number is K914196.

When did RONDEX MASKS MODELS 9015/9011/901102 MODIFIED receive FDA 510(k) clearance?

RONDEX MASKS MODELS 9015/9011/901102 MODIFIED received FDA 510(k) clearance on 1991-11-08, under 510(k) number K914196.

Who is the listed applicant for RONDEX MASKS MODELS 9015/9011/901102 MODIFIED?

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

What is the FDA product code for RONDEX MASKS MODELS 9015/9011/901102 MODIFIED?

The FDA product code for RONDEX MASKS MODELS 9015/9011/901102 MODIFIED is BTM.

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Other records listing Rondex Products, 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.

K981169RONDEX CPR ISO-SHIELDK942671CPR SHIELDK943761NON-BREATHING VALVEK921002RONDEX MASK MODELS 9122/9111/9102/911102, MODIFIEDK914195RONDEX CPR NON REBREATHING VALVE #9030, MODIFIEDK902299CPR VALVE (NON-REBREATHING) MODEL #9030

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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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