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Fore-Sight Absolute Cerebral And Somatic Oximeter, Mc 2000 Series (Mc2000 +3 mo…

FDA 510(k)

Class II (US FDA 510(k))

510(k) K094030

by Cas Medical Systems, Inc.

Identifiers

510(k) Number
K094030 FDA 510(k)
FDA Product Code
MUD FDA 510(k)
Models / Variants
Mc2000 FDA 510(k)
Mc2010 FDA 510(k)
Mc2020 FDA 510(k)
Mc2030 FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2700 FDA 510(k)
Regulation Number
870.2700 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Fore-Sight Absolute Cerebral And Somatic Oximeter, Mc 2000 Series (Mc2000 +3 mo… by Cas Medical Systems, Inc. — Class II — FDA_510K — listed in FDA 510(k) — 4…

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Cas Medical Systems, Inc.

Sources (1)

  • FDA 510(k) K094030 24 fields · synced Jun 18, 2026