Skip to content

EchoNext 00

by Pathwai, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860016080300 UDI-DI Date31 Aug 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
EchoNext
Generic Name
Cardiopulmonary physiological parameter analysis software, professional-only
Model / Reference
00
Primary DI / UDI-DI
00860016080300
510(k) Number
FDA Product Code
QXO, QYE, SAT, SII, SIJ, SIK
GMDN Term
Cardiopulmonary physiological parameter analysis software, professional-only
Device Class
Class II
Regulation Number
870.2380
GUDID distribution status
In Commercial Distribution

Other devices from Pathwai, Inc.

  • EchoNext

    Class II

Properties

  • Serial Number

Other properties (13)

  • 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
  • Expiration Date: No
  • Manufacturing Date: No