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FDA 510(k)

PLUS REUSABLE RESUSCITATOR

K-Number: K974141 · 1998-05-21

ApplicantSchiff & Co.
Decision Date1998-05-21
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PLUS REUSABLE RESUSCITATOR is the device name listed in this FDA 510(k) record. The listed applicant is Schiff & Co.. It received FDA 510(k) clearance on 1998-05-21 under 510(k) number K974141. 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 PLUS REUSABLE RESUSCITATOR?

PLUS REUSABLE RESUSCITATOR is a medical device that received FDA 510(k) clearance on 1998-05-21. The listed applicant is Schiff & Co.. The 510(k) number is K974141.

When did PLUS REUSABLE RESUSCITATOR receive FDA 510(k) clearance?

PLUS REUSABLE RESUSCITATOR received FDA 510(k) clearance on 1998-05-21, under 510(k) number K974141.

Who is the listed applicant for PLUS REUSABLE RESUSCITATOR?

The FDA 510(k) record lists Schiff & Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PLUS REUSABLE RESUSCITATOR?

The FDA product code for PLUS REUSABLE RESUSCITATOR is BTM.

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Other records listing Schiff & Co. 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.

K990511X-TIP INTRAOSSEOUS PERFORATORK982136JOSTRA VENOUS HARDSHELL CARDIOTOMIC RESERVOIR VHK 4200K981629NUTRISAFE ENTERAL FEEDING TUBEK981630VYGON DOUBLE LUMEN UMBILICAL CATHETERK954448VIOTEC V-2200 ULTRAVIOLET GERMICIDAL AIR PURIFICATION SYSTEMK955085HM-CAP EIA TEST (MODIFICATION)

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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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