Identity
- Trade Name
- Welch Allyn, Inc. FDA UDI
- Generic Name
- Centralized patient monitor FDA UDI
- Device Name
- Surveyor Central Station with S4 Wifi telemetry monitoring capabilities; English language and CD manual; Configured CPU (custom SCNODE configuration must be determined) with 220V power and dual color LCD 24" monitors with high resolution; 0 hard wired patient monitoring slots and 16 telemetry channels (dual display recommended); Redundant server (RAID1+0) storage for up to 1,200 days, no network printer included; VERITAS analysis algorithm with 12-lead ECG interpretation, extended arrhythmia, 12 FDA UDI
- Model / Reference
- 901137 FDA UDI
- Description
- Surveyor Central Station with S4 Wifi telemetry monitoring capabilities; English language and CD manual; Configured CPU (custom SCNODE configuration must be determined) with 220V power and dual color LCD 24" monitors with high resolution; 0 hard wired patient monitoring slots and 16 telemetry channels (dual display recommended); Redundant server (RAID1+0) storage for up to 1,200 days, no network printer included; VERITAS analysis algorithm with 12-lead ECG interpretation, extended arrhythmia, 12 FDA UDI
Identifiers
- Catalog Number
- SCSYS-HAB-GDFEA FDA UDI
- Primary DI / UDI-DI
- 00732094314243 FDA UDI
- 510(k) Number
- K160685 FDA UDI
- FDA Product Code
- DPS FDA UDI
- GMDN Term
- Centralized patient monitor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2340 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
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Category: Centralized patient monitor
Welch Allyn, Inc. by Welch Allyn, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K160685 also covers:
- Surveyor Patient Cable — MORTARA INSTRUMENT, INC.
- Surveyor Patient Cable — MORTARA INSTRUMENT, INC.
- Surveyor Patient Cable — MORTARA INSTRUMENT, INC.
- Surveyor Patient Cable — MORTARA INSTRUMENT, INC.
- Surveyor Patient Cable — MORTARA INSTRUMENT, INC.
- Surveyor Patient Cable — MORTARA INSTRUMENT, INC.
- Surveyor Patient Cable — MORTARA INSTRUMENT, INC.
- Surveyor Patient Cable — MORTARA INSTRUMENT, INC.
- Surveyor Patient Cable — MORTARA INSTRUMENT, INC.
- Surveyor Patient Cable — MORTARA INSTRUMENT, INC.
- Surveyor Patient Cable — MORTARA INSTRUMENT, INC.
- Surveyor Patient Cable — MORTARA INSTRUMENT, 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 |
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Manufacturer
- Manufacturer
- Welch Allyn, Inc.
Sources (1)
- FDA UDI 75e06143-f623-4d21-b5e2-16350ca7c520 36 fields · synced May 31, 2026