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Datum

by Blease USA, Inc. 510(k)

Active United States

510(k) K942799

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK942799 Date13 Apr 1995ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
CAD
Device Class
Class II
Regulation
21 CFR Part 868.5880
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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