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FDA 510(k)

1ST RESPONSE DISPOSABLE MANOMETER

K-Number: K961318 · 1996-12-17

ApplicantIntertech Resources, Inc.
Decision Date1996-12-17
Product CodeCAP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

1ST RESPONSE DISPOSABLE MANOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Intertech Resources, Inc.. It received FDA 510(k) clearance on 1996-12-17 under 510(k) number K961318. The device is classified under product code CAP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 1ST RESPONSE DISPOSABLE MANOMETER?

1ST RESPONSE DISPOSABLE MANOMETER is a medical device that received FDA 510(k) clearance on 1996-12-17. The listed applicant is Intertech Resources, Inc.. The 510(k) number is K961318.

When did 1ST RESPONSE DISPOSABLE MANOMETER receive FDA 510(k) clearance?

1ST RESPONSE DISPOSABLE MANOMETER received FDA 510(k) clearance on 1996-12-17, under 510(k) number K961318.

Who is the listed applicant for 1ST RESPONSE DISPOSABLE MANOMETER?

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

What is the FDA product code for 1ST RESPONSE DISPOSABLE MANOMETER?

The FDA product code for 1ST RESPONSE DISPOSABLE MANOMETER is CAP.

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Other records listing Intertech Resources, 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.

K955008HEAT & MOISTURE EXCHANGERK953580HEAT MOISTURE EXCHANGERK952223XENON GAS BREATHING CIRCUITK952214SIMS INTERTECH HYPERINFLATION BAG SYSTEMK952062PFT FILTERK952169SAFE RESPONSE MOUTH-TO-MASK RESUSCITATOR, PEDIATRIC

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Related Devices (Code: CAP)

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.

K201666SINGLE USE MANOMETERFlexicare Medical Limited.K182292VORTRAN APM-PlusVortran Medical Technology 1, Inc.K180510NS 120P-TRS Airway Pressure GaugeInstrumentation Industries, Inc.K172284NAPA LP-15 Airway Pressure MonitorDrw Medical, LLCK153733VORTRAN ManometerVortran Medical Technology 1, Inc.K122627GIO DIGITAL PRESSURE GUAGESGalemed Corp.

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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