← Back to catalogue

Anspach Eg1 High Speed System, G1 Attachments

FDA 510(k)

Class II (US FDA 510(k))

510(k) K133604

by The Anspach Effort, Inc.

Identifiers

510(k) Number
K133604 FDA 510(k)
FDA Product Code
HBC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.4360 FDA 510(k)
Regulation Number
882.4360 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Anspach Eg1 High Speed System, G1 Attachments by The Anspach Effort, 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

Sources (1)

  • FDA 510(k) K133604 24 fields · synced Jun 18, 2026