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FDA 510(k)

GAMBRO ULTRASONIC BLOOD LEVEL DETECTOR ULD 10-200

K-Number: K860076 · 1986-05-30

ApplicantGambro, Inc.
Decision Date1986-05-30
Product CodeDTW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GAMBRO ULTRASONIC BLOOD LEVEL DETECTOR ULD 10-200 is the device name listed in this FDA 510(k) record. The listed applicant is Gambro, Inc.. It received FDA 510(k) clearance on 1986-05-30 under 510(k) number K860076. 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 GAMBRO ULTRASONIC BLOOD LEVEL DETECTOR ULD 10-200?

GAMBRO ULTRASONIC BLOOD LEVEL DETECTOR ULD 10-200 is a medical device that received FDA 510(k) clearance on 1986-05-30. The listed applicant is Gambro, Inc.. The 510(k) number is K860076.

When did GAMBRO ULTRASONIC BLOOD LEVEL DETECTOR ULD 10-200 receive FDA 510(k) clearance?

GAMBRO ULTRASONIC BLOOD LEVEL DETECTOR ULD 10-200 received FDA 510(k) clearance on 1986-05-30, under 510(k) number K860076.

Who is the listed applicant for GAMBRO ULTRASONIC BLOOD LEVEL DETECTOR ULD 10-200?

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

What is the FDA product code for GAMBRO ULTRASONIC BLOOD LEVEL DETECTOR ULD 10-200?

The FDA product code for GAMBRO ULTRASONIC BLOOD LEVEL DETECTOR ULD 10-200 is DTW.

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Other records listing Gambro, 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.

K083158EXALIS, SOFTWARE VERSION 1.15K070643PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35K032431PRISMA M60/M100 SETSK896758GAMBRO BICARBONATE MONITOR BCM 10-3K896757GAMBRO AK-10 DIALYSIS SYSTEM FOR HIGH FLOWSK902481GAMBRO ALWALL GFS PLUS 11, 16 & 20 HOLLOW FIBER

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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.K924354STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITORSorin Biomedica, Fiat, USA, Inc.K915337CAPIOX LEVEL ALARMTerumo Medical 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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