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FDA 510(k)

STROLLER SPRINT

K-Number: K841808 · 1984-05-16

ApplicantCryogenic Assoc.
Decision Date1984-05-16
Product CodeBYJ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

STROLLER SPRINT is the device name listed in this FDA 510(k) record. The listed applicant is Cryogenic Assoc.. It received FDA 510(k) clearance on 1984-05-16 under 510(k) number K841808. The device is classified under product code BYJ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STROLLER SPRINT?

STROLLER SPRINT is a medical device that received FDA 510(k) clearance on 1984-05-16. The listed applicant is Cryogenic Assoc.. The 510(k) number is K841808.

When did STROLLER SPRINT receive FDA 510(k) clearance?

STROLLER SPRINT received FDA 510(k) clearance on 1984-05-16, under 510(k) number K841808.

Who is the listed applicant for STROLLER SPRINT?

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

What is the FDA product code for STROLLER SPRINT?

The FDA product code for STROLLER SPRINT is BYJ.

Related Clinical Trials

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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Other records listing Cryogenic Assoc. 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.

K883590OXYTROLK852663PORTABLE GASEOUS OXGYEN CONTAINERK822789ROOMATE IIK800742LIBERATOR/STROLLER II SYSTEMK801104ROOMMATE-OXYGEN CONCENTRATOR

Related Devices (Code: BYJ)

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.

K130068DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS)Essex Industries, Inc. D/B/A Essex Cryogenics of MK113767MOUNTED MEDICAL OXYGEN SYSTEMEssex Industries, Inc.K103324PRECISION LIQUID OXYGEN SYSTEMPrecision Medical, Inc.K101272MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3Essex Industries, Inc.K081779GOLOX-93Respironics, Inc.K080023MODIFICATION TO: SPIRITCaire, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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