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FDA 510(k)

BABI PLUS NEONATAL RESUSCITATION BAG

K-Number: K112852 · 2012-01-13

ApplicantA Plus Medical
Decision Date2012-01-13
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BABI PLUS NEONATAL RESUSCITATION BAG is the device name listed in this FDA 510(k) record. The listed applicant is A Plus Medical. It received FDA 510(k) clearance on 2012-01-13 under 510(k) number K112852. 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 BABI PLUS NEONATAL RESUSCITATION BAG?

BABI PLUS NEONATAL RESUSCITATION BAG is a medical device that received FDA 510(k) clearance on 2012-01-13. The listed applicant is A Plus Medical. The 510(k) number is K112852.

When did BABI PLUS NEONATAL RESUSCITATION BAG receive FDA 510(k) clearance?

BABI PLUS NEONATAL RESUSCITATION BAG received FDA 510(k) clearance on 2012-01-13, under 510(k) number K112852.

Who is the listed applicant for BABI PLUS NEONATAL RESUSCITATION BAG?

The FDA 510(k) record lists A Plus Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BABI PLUS NEONATAL RESUSCITATION BAG?

The FDA product code for BABI PLUS NEONATAL RESUSCITATION BAG is BTM.

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Other records listing A Plus Medical 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.

K110471BABI PLUS INFANT NASAL CANNULA SYSTEMK110383BABI*PLUS PRESSURE RELIEF MANIFOLD - 10CM H20, 12.5CM H20, 15CM H20K102377VENTIPLUS DISPOSABLE MANOMETER 0-60 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0-20 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0K093716BABI PLUS INFANT NASAL CANNULA SYSTEMK092687VENTI.PLUS HYPERINFLATION BAG SYSTEM WITH PRESSURE MANOMETERK090317BABI*PLUS BUBBLE PAP VALVE

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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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