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Rembrandt System

by Airsep Corp.

510(k) K962865

Rembrandt System is a Class II device made by Airsep Corp., cleared under FDA 510(k) K962865 on 25 Oct 1996, active as of 10 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 10 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 10 Oct 2026.

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)ST Traditional NumberK962865 Date25 Oct 1996DecidedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
FLS
Device class
Class II
Regulation
21 CFR Part 868.2377
Advisory committee
Anesthesiology
FDA decision
ST

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