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FDA 510(k)

CUSHION-FLEX TM

K-Number: K843169 · 1984-08-20

ApplicantLife Design Systems, Inc.
Decision Date1984-08-20
Product CodeBSJ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CUSHION-FLEX TM is the device name listed in this FDA 510(k) record. The listed applicant is Life Design Systems, Inc.. It received FDA 510(k) clearance on 1984-08-20 under 510(k) number K843169. The device is classified under product code BSJ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUSHION-FLEX TM?

CUSHION-FLEX TM is a medical device that received FDA 510(k) clearance on 1984-08-20. The listed applicant is Life Design Systems, Inc.. The 510(k) number is K843169.

When did CUSHION-FLEX TM receive FDA 510(k) clearance?

CUSHION-FLEX TM received FDA 510(k) clearance on 1984-08-20, under 510(k) number K843169.

Who is the listed applicant for CUSHION-FLEX TM?

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

What is the FDA product code for CUSHION-FLEX TM?

The FDA product code for CUSHION-FLEX TM is BSJ.

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Other records listing Life Design Systems, 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.

K913714MODIFICATION MANUAL PULMON RESUSCITOR/PULMANEX(TM)K885313HUMIDI-FLEX TMK893030CHILD SIZE - FILTER FLEX (TM)K892862FLEX-CUP PERCUSSORK892221PULMONARY RESUSCITATOR, MODIFICATIONK890011OXYGEN CONNECTOR AND OXYGEN DELIVERY TUBING

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Related Devices (Code: BSJ)

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.

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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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