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Ultraview 90478

by Spacelabs Healthcare (Washington), Inc 23 variants

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 Number10841522105487 UDI-DI Date23 Jan 2019ListedStatusListed 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  • Withdrawn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
Ultraview
Generic Name
Electrocardiography monitoring system receiver
Model / Reference
90478
Primary DI / UDI-DI
10841522105487
510(k) Number
FDA Product Code
MHX
GMDN Term
Electrocardiography monitoring system receiver
Device Class
Class II
Regulation Number
870.1025
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K983996)

Show all (10)

Other devices from Spacelabs Healthcare (Washington), Inc

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Properties

  • Prescription Use
  • Serial Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: 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