Tecnotomo
FDA 510(k) K790132 · Teknomed, Inc.
510(k) numberK790132
Submission
- Device name
- Tecnotomo
- Applicant
- Teknomed, Inc.
Mchenry, IL, US - Received
- January 23, 1979
- Decision date
- February 21, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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More from Ge Medical Systems, LLC
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| K925395 | Technomed Pulsolith 4000 Laser SystemLNK · Traditional | 05/21/1993SE |
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| K913917 | Multilase 2100 C, 2100 DGEX · Traditional | 11/05/1992SE |
| K913290 | Multilase 2100 aGEX · Traditional | 02/21/1992SE |
| K895178 | Technomed Pulsolith Laser SystemFFK · Traditional | 10/06/1989SE |
| K890436 | Technomed Pulsolith Laser SystemFFK · Traditional | 03/23/1989SE |
Questions and answers
When was Tecnotomo cleared by the FDA?
Tecnotomo (K790132) received a 510(k) decision of Substantially Equivalent on February 21, 1979, 29 days after the submission was received.
What is the product code of K790132?
The FDA product code is IZF – System, X-Ray, Tomographic, a Class II (moderate risk) device regulated under 21 CFR 892.1740.