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Spiroloop

by Datamed, Inc. 510(k)

Active United States

510(k) K841858

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK841858 Date11 Jul 1984ClearedStatusActive

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  • Withdrawn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 10 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
BSE
Device Class
Class II
Regulation
21 CFR Part 868.1640
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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