← Back to catalogue

Gambro Ultrasonic Blood Level Detector Uld 10-200

FDA 510(k)

Class II (US FDA 510(k))

510(k) K860076

by Gambro, Inc.

Identifiers

510(k) Number
K860076 FDA 510(k)
FDA Product Code
DTW FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.4340 FDA 510(k)
Regulation Number
870.4340 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Gambro Ultrasonic Blood Level Detector Uld 10-200 by Gambro, Inc. — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Gambro, Inc.

Sources (1)

  • FDA 510(k) K860076 24 fields · synced Jun 18, 2026