Identity
- Trade Name
- Ultralite FDA UDI
- Generic Name
- Electrocardiography monitoring system receiver FDA UDI
- Device Name
- R-90478, T-BAND UHF,602-608MHZ FDA UDI
- Model / Reference
- Ultralite FDA UDI
- Description
- R-90478, T-BAND UHF,602-608MHZ FDA UDI
Identifiers
- Catalog Number
- R-90478-T FDA UDI
- Primary DI / UDI-DI
- 10841522108426 FDA UDI
- 510(k) Number
- K983996 FDA UDI
- FDA Product Code
- MHX FDA UDI
- GMDN Term
- Electrocardiography monitoring system receiver FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1025 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electrocardiography monitoring system receiver
Ultralite by Spacelabs Healthcare (washington), Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electrocardiography monitoring system receiver.
- Abyssal — ABYSSAL, K.K. · Class II
- Norav 1200 Series PC-ECG — Norav Medical Inc. · Class II
- prolaio Personalized Physiology Analytics Engine Software (PPA) — Prolaio, Inc. · Class II
- prolaio Convenience Kit — Prolaio, Inc.
- Abyssal — ABYSSAL, K.K. · Class II
- Abyssal — ABYSSAL, K.K. · Class II
- Vectraplex CMS — Vectracor, Inc. · Class II
- LifeSync — Advantage Medical Electronics, LLC · Class II
Cleared under the same submission
K983996 also covers:
- TRULINK — SPACELABS HEALTHCARE (WASHINGTON), INC
- TRULINK — SPACELABS HEALTHCARE (WASHINGTON), INC
- TRULINK — SPACELABS HEALTHCARE (WASHINGTON), INC
- TRULINK — SPACELABS HEALTHCARE (WASHINGTON), INC
- TRULINK — SPACELABS HEALTHCARE (WASHINGTON), INC
- Trulink — SPACELABS HEALTHCARE (WASHINGTON), INC
- Trulink — SPACELABS HEALTHCARE (WASHINGTON), INC
- Ultralite — SPACELABS HEALTHCARE (WASHINGTON), INC
- Ultralite — SPACELABS HEALTHCARE (WASHINGTON), INC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Spacelabs Healthcare (washington), Inc
Sources (1)
- FDA UDI 6f412b33-1720-4892-b304-99153663a793 36 fields · synced May 30, 2026