Auto Therm 390, Model Me 390
FDA 510(k) K042554 · Mettler Electronics Corp.
510(k) numberK042554
Submission
- Device name
- Auto Therm 390, Model Me 390
- Applicant
- Mettler Electronics Corp.
Anaheim, CA, US - Received
- September 20, 2004
- Decision date
- October 8, 2004
- 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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Questions and answers
When was Auto Therm 390, Model Me 390 cleared by the FDA?
Auto Therm 390, Model Me 390 (K042554) received a 510(k) decision of Substantially Equivalent on October 8, 2004, 18 days after the submission was received.
What is the product code of K042554?
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.