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Accuflo Monitoring System (1800)/ Accuflo Probe (8000)

by International Biophysics Corp.

510(k) K963703

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK963703 Date8 Apr 1998ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1223-06 FDA Unclassified (pre-2012) initiated 22 Apr 2005

    Complaints received regarding the device's failure to zero out.

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  • Withdrawn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
DPT
Device Class
Class II
Regulation
21 CFR Part 870.2120
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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