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Astral Disposable Skin Temperature Probe

by Astral, Ltd. 510(k) 2 variants

Active United States

510(k) K946005

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK946005 Date25 Sep 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  • Withdrawn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
FMT
Device Class
Class II
Regulation
21 CFR Part 880.5130
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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