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FDA 510(k)

HEADSTRAP

K-Number: K854537 · 1985-12-03

ApplicantLife Design Systems, Inc.
Decision Date1985-12-03
Product CodeBTK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HEADSTRAP 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 1985-12-03 under 510(k) number K854537. The device is classified under product code BTK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEADSTRAP?

HEADSTRAP is a medical device that received FDA 510(k) clearance on 1985-12-03. The listed applicant is Life Design Systems, Inc.. The 510(k) number is K854537.

When did HEADSTRAP receive FDA 510(k) clearance?

HEADSTRAP received FDA 510(k) clearance on 1985-12-03, under 510(k) number K854537.

Who is the listed applicant for HEADSTRAP?

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 HEADSTRAP?

The FDA product code for HEADSTRAP is BTK.

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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: BTK)

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.

K944949GENERAL ANESTHESIA SYSTEMVital Signs, Inc.K914335STRAP, HEAD, GAS MASKVital Signs, Inc.K853573MEDIPART FACE MASK HEADSTRAP MP-9100Medipart Jerry AlexanderK831008HEAD STRAPMedovations, Inc.K810991HEADSTRAPRespironics, Inc.

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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