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AISAP Cardio V1.0 2.X.Y.Z

by Aisap

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberG762AISAPCARDIOV10 UDI-DI Date18 Feb 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
AISAP Cardio V1.0
Generic Name
Ultrasound imaging system application software
Model / Reference
2.X.Y.Z
Primary DI / UDI-DI
G762AISAPCARDIOV10
510(k) Number
FDA Product Code
POK, QIH
GMDN Term
Ultrasound imaging system application software
Device Class
Class II
Regulation Number
892.2060, 892.2050
GUDID distribution status
In Commercial Distribution

Other devices from Aisap

Properties

Other properties (14)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No