TEC
TEC 820 ISO
1manufacturer
4catalogue numbers in this listing
6510(k) clearances naming this product code
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
Record
| Listed by | Datex-Ohmeda, Inc., United States |
|---|---|
| FDA product code | CAD |
| Device type | Vaporizer, Anesthesia, Non-Heated |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5880 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K172702 |
| Record published | 2018-03-12 |
| Record revised | 2022-05-12 (version 3) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Label carries | serial number |
| Storage | Storage environment atmospheric pressure 53 to 106 KiloPascal; Storage environment temperature -25 to 60 °C; Storage environment humidity 15 to 95 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 820 ISO | In distribution | |
| 820 SEV | In distribution | |
| 850 SEV | In distribution | |
| 850 ISO | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Spacelabs Healthcare | Spacelabs Healthcare (Washington), Inc | 107 |
| Penlon | Penlon Ltd. | 11 |
| TEC 7 | Datex-Ohmeda, Inc. | 10 |
| Antispil | Southmedic, Inc. | 5 |
| Vapofil™ | Southmedic, Inc. | 5 |
| TEC 6 Plus | Datex-Ohmeda, Inc. | 3 |
| AincA® | Anesthesia Associates, Inc. | 1 |
| Flexible arm assembly FRU | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 1 |
| V80 Anesthetic Vaporizer | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 1 |
| Sevoflurane Key Filler Vaporizer(FDA) | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 1 |
| Key Filler Bottle Adaptor MRI | Penlon Ltd. | 1 |
| Vapor 3000 | Drägerwerk AG & Co. KGaA | 1 |
Showing 12 of 20. All products under Vaporizer, Anesthesia, Non-Heated
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K172702 | 2018-01-04 |
| K031027 | 2003-06-26 |
| K012924 | 2002-01-30 |
| K002878 | 2000-09-21 |
| K000275 | 2000-04-12 |
| K990132 | 1999-01-21 |
Recalls Naming This Product
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| GE Medical Systems, LLC | 510(k) number | 2024-11-18 | Class II | Process control | Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting. | 644 units |
| GE Medical Systems, LLC | 510(k) number | 2024-11-18 | Class II | Process control | Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting. | 928 units |
| GE Medical Systems, LLC | 510(k) number | 2024-11-18 | Class II | Process control | Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting. | 1594 units |
| GE Medical Systems, LLC | 510(k) number | 2024-11-18 | Class II | Process control | Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting. | 8319 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.