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Model 65 High & Low Pressure Alarm

by The John Bunn Co. 510(k)

Active United States

510(k) K780863

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK780863 Date21 Aug 1978ClearedStatusActive

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  • Withdrawn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
CAP
Device Class
Class II
Regulation
21 CFR Part 868.2600
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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