Skip to content

A-PULSE CASP® Pulse Wave Analysis System T6400 Series

by Healthstats International Pte Ltd

Listed FDA GUDID listing, not in commercial distribution

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 Number08885014410036 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: not 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  • Withdrawn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
A-PULSE CASP® Pulse Wave Analysis System
Generic Name
Blood pressure ambulatory recorder
Model / Reference
T6400 Series
Primary DI / UDI-DI
08885014410036
510(k) Number
FDA Product Code
DXN
GMDN Term
Blood pressure ambulatory recorder
Device Class
Class II
Regulation Number
870.1130
GUDID distribution status
Not in Commercial Distribution

Other devices from Healthstats International Pte Ltd

See all devices from Healthstats International Pte Ltd →

Properties

  • Combination Product
  • Serial Number

Other properties (12)

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