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FDA 510(k)

MODIFICATION TO VENTLAB HYPERINFLATION BAG SYSTEM

K-Number: K020281 · 2002-02-11

ApplicantVentlab Corp.
Decision Date2002-02-11
Product CodeNHK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO VENTLAB HYPERINFLATION BAG SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ventlab Corp.. It received FDA 510(k) clearance on 2002-02-11 under 510(k) number K020281. 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 MODIFICATION TO VENTLAB HYPERINFLATION BAG SYSTEM?

MODIFICATION TO VENTLAB HYPERINFLATION BAG SYSTEM is a medical device that received FDA 510(k) clearance on 2002-02-11. The listed applicant is Ventlab Corp.. The 510(k) number is K020281.

When did MODIFICATION TO VENTLAB HYPERINFLATION BAG SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO VENTLAB HYPERINFLATION BAG SYSTEM received FDA 510(k) clearance on 2002-02-11, under 510(k) number K020281.

Who is the listed applicant for MODIFICATION TO VENTLAB HYPERINFLATION BAG SYSTEM?

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

What is the FDA product code for MODIFICATION TO VENTLAB HYPERINFLATION BAG SYSTEM?

The FDA product code for MODIFICATION TO VENTLAB HYPERINFLATION BAG SYSTEM is NHK.

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Other records listing Ventlab Corp. 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.

K120118VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETERK102674CUFF SENTRYK093617VENTLAB 6000 SERIES HUMIDIFIERK093525ACE/STATCHECK II CO2 INDICATOR, ACE/STATCHECK II CO2 INDICATOR ARM ASSEMBY ADULT STATCHECK RESUSCITATOR WITH ACE/STATCHEK090840VENTLAB 5000 SERIES NEBULIZER ASSEMBLY, CUP, CUP W/ MASK, CUP W/ FITSALL CONN.K082204SERIES SY DISPOSABLE ELECTROSURGICAL PAD

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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 MedicalK013308VENTLAB HYPERINFLATION BAG SYSTEMVentlab Corp.K001714MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149Mercury MedicalK970785SIMS HYPERINFLATION BAG SYSTEMSimsK952214SIMS 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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