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FDA 510(k)

AIR VIVA II

K-Number: K802231 · 1980-10-10

ApplicantGeneral Medical Co.
Decision Date1980-10-10
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AIR VIVA II is the device name listed in this FDA 510(k) record. The listed applicant is General Medical Co.. It received FDA 510(k) clearance on 1980-10-10 under 510(k) number K802231. 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 AIR VIVA II?

AIR VIVA II is a medical device that received FDA 510(k) clearance on 1980-10-10. The listed applicant is General Medical Co.. The 510(k) number is K802231.

When did AIR VIVA II receive FDA 510(k) clearance?

AIR VIVA II received FDA 510(k) clearance on 1980-10-10, under 510(k) number K802231.

Who is the listed applicant for AIR VIVA II?

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

What is the FDA product code for AIR VIVA II?

The FDA product code for AIR VIVA II is BTM.

Other records listing General Medical 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.

K926269PROCEDURE KITK912975OPERAND LUBRICATING JELLYK912132OPERAND LUBRICATING JELLYK903669GENESIS INSUFFLATING CATHETERK900110OPERAND* LUBRICATING JELLYK853635SUBDERM TM

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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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