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FDA 510(k)

GAMBRO-ENGSTROM ERICA IV RESPIRATOR

K-Number: K872482 · 1988-03-03

ApplicantGambro, Inc.
Decision Date1988-03-03
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

GAMBRO-ENGSTROM ERICA IV RESPIRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Gambro, Inc.. It received FDA 510(k) clearance on 1988-03-03 under 510(k) number K872482. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAMBRO-ENGSTROM ERICA IV RESPIRATOR?

GAMBRO-ENGSTROM ERICA IV RESPIRATOR is a medical device that received FDA 510(k) clearance on 1988-03-03. The listed applicant is Gambro, Inc.. The 510(k) number is K872482.

When did GAMBRO-ENGSTROM ERICA IV RESPIRATOR receive FDA 510(k) clearance?

GAMBRO-ENGSTROM ERICA IV RESPIRATOR received FDA 510(k) clearance on 1988-03-03, under 510(k) number K872482.

Who is the listed applicant for GAMBRO-ENGSTROM ERICA IV RESPIRATOR?

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

What is the FDA product code for GAMBRO-ENGSTROM ERICA IV RESPIRATOR?

The FDA product code for GAMBRO-ENGSTROM ERICA IV RESPIRATOR is CBK.

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Other records listing Gambro, 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.

K083158EXALIS, SOFTWARE VERSION 1.15K070643PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35K032431PRISMA M60/M100 SETSK896758GAMBRO BICARBONATE MONITOR BCM 10-3K896757GAMBRO AK-10 DIALYSIS SYSTEM FOR HIGH FLOWSK902481GAMBRO ALWALL GFS PLUS 11, 16 & 20 HOLLOW FIBER

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Related Devices (Code: CBK)

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.

K253647Evita (V800); Evita (V600)Draegerwerk AG & CO KgaaK252663Inbentus VersatileIconic Solutions by Murcia, SLK251888VPAP Pediatric Face MaskHsiner Co., Ltd.K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.K252173F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented FullFisher & Paykel Healthcare, Ltd.K243767SV600, SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.

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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