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FDA 510(k)

STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITOR

K-Number: K924354 · 1993-02-18

ApplicantSorin Biomedica, Fiat, USA, Inc.
Decision Date1993-02-18
Product CodeDTW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Sorin Biomedica, Fiat, USA, Inc.. It received FDA 510(k) clearance on 1993-02-18 under 510(k) number K924354. The device is classified under product code DTW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITOR?

STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITOR is a medical device that received FDA 510(k) clearance on 1993-02-18. The listed applicant is Sorin Biomedica, Fiat, USA, Inc.. The 510(k) number is K924354.

When did STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITOR receive FDA 510(k) clearance?

STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITOR received FDA 510(k) clearance on 1993-02-18, under 510(k) number K924354.

Who is the listed applicant for STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITOR?

The FDA 510(k) record lists Sorin Biomedica, Fiat, USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITOR?

The FDA product code for STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITOR is DTW.

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Other records listing Sorin Biomedica, Fiat, USA, 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.

K931444PLEXUS 2 & 3.5 HOLLOW FIBER OXYGENATORSK925661STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULEK925369BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMSK925615SHILEY SPECIALIZED,PEDIATRIC & NEONATAL TRACH.TUBEK925541STOCKERT 1/4 BUBBLE SENSORK922933SORIN MONOLYRH INTEGRATED MEMBRANE LUNG

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Related Devices (Code: DTW)

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.

K041558STOCKERTIR PURGE CONTROL (APC) SYSTEMStockert Instrumente GmbHK992857LEVELSENS - FLEXIBLE, MODEL 201110, LEVELSENS - RIGID, MODEL 201070Rocky Mountain Research, Inc.K955152STOCKERT S3 UPS, LVL CTRL BUBB. DET., DUAL PRESS. CTRL., TEMP MONT., TIMERStoeckert InstrumenteK910599CARDIOPULMONARY BYPASS LEVEL SENSING MONITORJtl Medical Corp.K915337CAPIOX LEVEL ALARMTerumo Medical Corp.K900910COBE AIR EMBOLI PROTECTION SYSTEM (AEPS)Cobe Laboratories, 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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