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FDA 510(k)

TONOMETERED SLAINE BLOOD GAS CONTROL

K-Number: K961441 · 1996-04-30

ApplicantInstrumentarium Corp.
Decision Date1996-04-30
Product CodeJJS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TONOMETERED SLAINE BLOOD GAS CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentarium Corp.. It received FDA 510(k) clearance on 1996-04-30 under 510(k) number K961441. The device is classified under product code JJS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TONOMETERED SLAINE BLOOD GAS CONTROL?

TONOMETERED SLAINE BLOOD GAS CONTROL is a medical device that received FDA 510(k) clearance on 1996-04-30. The listed applicant is Instrumentarium Corp.. The 510(k) number is K961441.

When did TONOMETERED SLAINE BLOOD GAS CONTROL receive FDA 510(k) clearance?

TONOMETERED SLAINE BLOOD GAS CONTROL received FDA 510(k) clearance on 1996-04-30, under 510(k) number K961441.

Who is the listed applicant for TONOMETERED SLAINE BLOOD GAS CONTROL?

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 TONOMETERED SLAINE BLOOD GAS CONTROL?

The FDA product code for TONOMETERED SLAINE BLOOD GAS CONTROL is JJS.

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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 IQK962638TONOCAP, TC-200 AND ACCESSORY CATHETERS

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Related Devices (Code: JJS)

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.

K152553CueSee HypoxicEurotrol B.V.K130415HIGH METABOLITE QUALICHECKRadiometer Medical ApsK130236RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3Radiometer Medical ApsK033063MISSION CONTROLSDiamond Diagnostics, Inc.K022525LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS, 1,2 AND 3, MODEL 507, 508, 509Bio-RadK022529LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL SYNTHESIS SERIES) LEVELS 1,2, AND 3, MODELS 667,668,669Bio-Rad

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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