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FDA 510(k)

4A

K-Number: K842122 · 1985-01-18

ApplicantLife Products, Inc.
Decision Date1985-01-18
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

4A is the device name listed in this FDA 510(k) record. The listed applicant is Life Products, Inc.. It received FDA 510(k) clearance on 1985-01-18 under 510(k) number K842122. 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 4A?

4A is a medical device that received FDA 510(k) clearance on 1985-01-18. The listed applicant is Life Products, Inc.. The 510(k) number is K842122.

When did 4A receive FDA 510(k) clearance?

4A received FDA 510(k) clearance on 1985-01-18, under 510(k) number K842122.

Who is the listed applicant for 4A?

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

What is the FDA product code for 4A?

The FDA product code for 4A is CBK.

Other records listing Life Products, 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.

K901714LIFESTYLE HOME TANNING UNITSK854022LPA-1 PRESSURE MONITORK850151L100B UNIVERSAL & L100A NIGHT PATIENT CIRCUITK851905LPA-2 REMOTE ALARMK851805LPA-3 PRINTERK844179LP-5

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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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