Auto*Therm 395, Model Me 395
FDA 510(k) K022458 · Mettler Electronics Corp.
510(k) numberK022458
Submission
- Device name
- Auto*Therm 395, Model Me 395
- Applicant
- Mettler Electronics Corp.
Anaheim, CA, US - Received
- July 26, 2002
- Decision date
- September 26, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- IMJ – Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5290
- Specialty
- Physical Medicine
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| K043586 | Laser Sys*Stim 540, Model Me 540ILY · Abbreviated | 05/06/2005SE |
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| K031017 | Sys*Stim 208 and 208AIPF · Traditional | 05/30/2003SE |
Questions and answers
When was Auto*Therm 395, Model Me 395 cleared by the FDA?
Auto*Therm 395, Model Me 395 (K022458) received a 510(k) decision of Substantially Equivalent on September 26, 2002, 62 days after the submission was received.
What is the product code of K022458?
The FDA product code is IMJ – Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat, a Class II (moderate risk) device regulated under 21 CFR 890.5290.