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Pascall Systems, Inc. PSU1

by Pascall Systems, 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 Number00860014334320 UDI-DI Date4 Sep 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  • Withdrawn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
Pascall Systems, Inc.
Generic Name
Electroencephalographic monitoring system
Model / Reference
PSU1
Primary DI / UDI-DI
00860014334320
510(k) Number
FDA Product Code
GXY, OLT, OMC, ORT
GMDN Term
Electroencephalographic monitoring system
Device Class
Class II
Regulation Number
882.1320, 882.1400
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Other devices from Pascall Systems, Inc.

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number

Other properties (11)

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