Identity
- Trade Name
- TEL-100 waterproof case(3lead IEC SNAP) FDA UDI
- Generic Name
- General-purpose multi-parameter bedside monitor FDA UDI
- Model / Reference
- 115-010668-00 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944904040776 FDA UDI
- 510(k) Number
- K162607 FDA UDI
- FDA Product Code
- MSX FDA UDI
- GMDN Term
- General-purpose multi-parameter bedside monitor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2300 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: General-purpose multi-parameter bedside monitor
TEL-100 waterproof case(3lead IEC SNAP) by Shenzhen Mindray Bio-Medical Electronics Co. — Class II — FDA UDI — listed in FDA GUDID
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Cleared under the same submission
K162607 also covers:
- 0155 Signal Converter Pack(LED Adapter) — Shenzhen Mindray Bio-Medical Electronics Co.
- 0155 Signal Converter Package(With LED) — Shenzhen Mindray Bio-Medical Electronics Co.
- 0155 Signal Repeater Package — Shenzhen Mindray Bio-Medical Electronics Co.
- Active Antenna Kit — Shenzhen Mindray Bio-Medical Electronics Co.
- BP10 Li-ion battery Package — Shenzhen Mindray Bio-Medical Electronics Co.
- CS 1U Host Package (HPE DL360G9) — Shenzhen Mindray Bio-Medical Electronics Co.
- CS host package (2U Rack) — Shenzhen Mindray Bio-Medical Electronics Co.
- CS host package (Tower PC) — Shenzhen Mindray Bio-Medical Electronics Co.
- TEL-100 waterproof case(3lead AHA CLIP) — Shenzhen Mindray Bio-Medical Electronics Co.
- TEL-100 waterproof case(3lead AHA SNAP) — Shenzhen Mindray Bio-Medical Electronics Co.
- TEL-100 waterproof case(3lead IEC CLIP) — Shenzhen Mindray Bio-Medical Electronics Co.
- TEL-100 waterproof case(5lead AHA CLIP) — Shenzhen Mindray Bio-Medical Electronics Co.
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
- Shenzhen Mindray Bio-Medical Electronics Co.
Sources (1)
- FDA UDI f688c3fb-61e1-4000-9b14-9fafd47b6255 34 fields · synced May 30, 2026