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FDA 510(k)

SIMS HYPERINFLATION BAG SYSTEM

K-Number: K970785 · 1997-06-13

ApplicantSims
Decision Date1997-06-13
Product CodeNHK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SIMS HYPERINFLATION BAG SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sims. It received FDA 510(k) clearance on 1997-06-13 under 510(k) number K970785. The device is classified under product code NHK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIMS HYPERINFLATION BAG SYSTEM?

SIMS HYPERINFLATION BAG SYSTEM is a medical device that received FDA 510(k) clearance on 1997-06-13. The listed applicant is Sims. The 510(k) number is K970785.

When did SIMS HYPERINFLATION BAG SYSTEM receive FDA 510(k) clearance?

SIMS HYPERINFLATION BAG SYSTEM received FDA 510(k) clearance on 1997-06-13, under 510(k) number K970785.

Who is the listed applicant for SIMS HYPERINFLATION BAG SYSTEM?

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

What is the FDA product code for SIMS HYPERINFLATION BAG SYSTEM?

The FDA product code for SIMS HYPERINFLATION BAG SYSTEM is NHK.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Sims 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.

K972283SIMS 1ST RESPONSE MANUAL RESUSCITATOR, ADULT

Related Devices (Code: NHK)

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.

K092687VENTI.PLUS HYPERINFLATION BAG SYSTEM WITH PRESSURE MANOMETERA Plus MedicalK020281MODIFICATION TO VENTLAB HYPERINFLATION BAG SYSTEMVentlab Corp.K013308VENTLAB HYPERINFLATION BAG SYSTEMVentlab Corp.K001714MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149Mercury MedicalK952214SIMS INTERTECH HYPERINFLATION BAG SYSTEMIntertech Resources, Inc.K942571HYPER-INFLATION BAGMed-Plastics Intl., 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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