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FDA 510(k)

TONOCAP, TC-200 AND ACCESSORY CATHETERS

K-Number: K962638 · 1997-04-04

ApplicantInstrumentarium Corp.
Decision Date1997-04-04
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TONOCAP, TC-200 AND ACCESSORY CATHETERS is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentarium Corp.. It received FDA 510(k) clearance on 1997-04-04 under 510(k) number K962638. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TONOCAP, TC-200 AND ACCESSORY CATHETERS?

TONOCAP, TC-200 AND ACCESSORY CATHETERS is a medical device that received FDA 510(k) clearance on 1997-04-04. The listed applicant is Instrumentarium Corp.. The 510(k) number is K962638.

When did TONOCAP, TC-200 AND ACCESSORY CATHETERS receive FDA 510(k) clearance?

TONOCAP, TC-200 AND ACCESSORY CATHETERS received FDA 510(k) clearance on 1997-04-04, under 510(k) number K962638.

Who is the listed applicant for TONOCAP, TC-200 AND ACCESSORY CATHETERS?

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

What is the FDA product code for TONOCAP, TC-200 AND ACCESSORY CATHETERS?

The FDA product code for TONOCAP, TC-200 AND ACCESSORY CATHETERS is CCK.

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Other records listing Instrumentarium 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.

K022630MODIFICATION TO FOCUSK001729FOCUSK001439ORTHOCEPH OC100 DK992385ORTHOPANTOMOGRAPH OP100DK981641MAMMOGRAPHY X-RAY EQUIPMENT MODELS MGF101 AND MGF110, ALPHA III, ALPHA ST, ALPHA RT AND ALPHA IQK961441TONOMETERED SLAINE BLOOD GAS CONTROL

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Related Devices (Code: CCK)

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.

K251641GF-310R Multigas Unit (GF-310R)Nihon Kohden CorporationK261633VisuBreathAffirm Medical Technologies II, LLCK253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLCK250148Medical Gas Analyzer (AG200)Prior Care Science Technology, Ltd.K243956TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)Nihon Kohden CorporationK2512160184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling lineBarbaras Development, 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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