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FDA 510(k)

NELLCOR INDGO MANUAL RESUSCITATOR

K-Number: K023494 · 2003-02-07

ApplicantNellcor Puritan Bennett, Inc.
Decision Date2003-02-07
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NELLCOR INDGO MANUAL RESUSCITATOR is the device name listed in this FDA 510(k) record. The listed applicant is Nellcor Puritan Bennett, Inc.. It received FDA 510(k) clearance on 2003-02-07 under 510(k) number K023494. 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 NELLCOR INDGO MANUAL RESUSCITATOR?

NELLCOR INDGO MANUAL RESUSCITATOR is a medical device that received FDA 510(k) clearance on 2003-02-07. The listed applicant is Nellcor Puritan Bennett, Inc.. The 510(k) number is K023494.

When did NELLCOR INDGO MANUAL RESUSCITATOR receive FDA 510(k) clearance?

NELLCOR INDGO MANUAL RESUSCITATOR received FDA 510(k) clearance on 2003-02-07, under 510(k) number K023494.

Who is the listed applicant for NELLCOR INDGO MANUAL RESUSCITATOR?

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

What is the FDA product code for NELLCOR INDGO MANUAL RESUSCITATOR?

The FDA product code for NELLCOR INDGO MANUAL RESUSCITATOR is BTM.

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Other records listing Nellcor Puritan Bennett, 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.

K070408DURAMAX REUSABLE OXIMETRY SENSORK060576NELLCOR OXIMAX N-600X PULSE OXIMETERK051271OXIMAX NEOMAX ADHESIVE FOREHEAD REFLECTANCE OXIMETRY SENSORK052186NELLCOR OXIMAX PULSE OXIMETRY SENSONS (MAX-A, MAX-AL, MAX-N, MAX-I, MAX-PK051352OXIMAX NPB-40 HANDHELD PULSE OXIMETERK050072GOODKNIGHT 425ST

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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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