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Tec 850 Iso
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref 1177-9850-ISOModel TEC 820 ISO, TEC 820 SEV, TEC 850 ISO, TEC 850 SEV
Identity
- Trade Name
- TEC 850 ISO EUDAMEDTEC FDA UDI
- Generic Name
- Isoflurane anaesthesia vaporizer FDA UDI
- Device Name
- TEC 820 ISO, TEC 820 SEV, TEC 850 ISO, TEC 850 SEV EUDAMEDTEC 850 ISO FDA UDI
- Model / Reference
- TEC 820 ISO, TEC 820 SEV, TEC 850 ISO, TEC 850 SEV EUDAMED1177-9850-ISO EUDAMED850 ISO FDA UDI
- Description
- TEC 850 ISO FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682124751 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00339HN EUDAMED
- 510(k) Number
- K172702 FDA UDI
- FDA Product Code
- CAD FDA UDI
- EMDN Code
- Z1203010180 ANAESTHESIA SYSTEMS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Isoflurane anaesthesia vaporizer FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5880 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
No
FDA UDI
MR Conditional FDA UDI
Tec 850 Iso by Datex-Ohmeda Inc. — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K172702 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 8406821BUG00339HN | Class IIb | Active |
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Manufacturer
- Manufacturer
- Datex-Ohmeda Inc.
- EUDAMED SRN
- US-MF-000014656
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (3)
- EUDAMED ad2fc2dd-1707-444b-a730-6d7e4aa48898 61 fields · synced Jul 11, 2026
- FDA UDI 5af13ad3-4e14-4719-b3e0-8537e43e22d4 35 fields · synced May 30, 2026
- FDA 510(k) K172702 1 fields · synced May 18, 2026