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Ti-1000 Transport Incubator

by Narco Scientific 510(k)

Active United States

510(k) K831028

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK831028 Date9 May 1983ClearedStatusActive

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  • Withdrawn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
FPL
Device Class
Class II
Regulation
21 CFR Part 880.5410
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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