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FDA 510(k)

AMBU SIR 2 (SILICONE RESUSCITATOR), ADULT

K-Number: K910040 · 1991-05-28

ApplicantAmbu, Inc.
Decision Date1991-05-28
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AMBU SIR 2 (SILICONE RESUSCITATOR), ADULT is the device name listed in this FDA 510(k) record. The listed applicant is Ambu, Inc.. It received FDA 510(k) clearance on 1991-05-28 under 510(k) number K910040. 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 AMBU SIR 2 (SILICONE RESUSCITATOR), ADULT?

AMBU SIR 2 (SILICONE RESUSCITATOR), ADULT is a medical device that received FDA 510(k) clearance on 1991-05-28. The listed applicant is Ambu, Inc.. The 510(k) number is K910040.

When did AMBU SIR 2 (SILICONE RESUSCITATOR), ADULT receive FDA 510(k) clearance?

AMBU SIR 2 (SILICONE RESUSCITATOR), ADULT received FDA 510(k) clearance on 1991-05-28, under 510(k) number K910040.

Who is the listed applicant for AMBU SIR 2 (SILICONE RESUSCITATOR), ADULT?

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

What is the FDA product code for AMBU SIR 2 (SILICONE RESUSCITATOR), ADULT?

The FDA product code for AMBU SIR 2 (SILICONE RESUSCITATOR), ADULT is BTM.

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Other records listing Ambu, 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.

K051529AMBU NEUROLINE GROUNDK042682AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATORK042843AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORSK041734AMBU DISPOSABLE ECG ELECTRODEK040991AMBU DISPOSABLE PRESSURE MANOMETERK041026AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S

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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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