Modified Sonicator 720, Model ME720
FDA 510(k) K880602 · Mettler Electronics Corp.
510(k) numberK880602
Submission
- Device name
- Modified Sonicator 720, Model ME720
- Applicant
- Mettler Electronics Corp.
Anaheim, CA, US - Received
- February 11, 1988
- Decision date
- February 25, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- IMI – Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5300
- Specialty
- Physical Medicine
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Questions and answers
When was Modified Sonicator 720, Model ME720 cleared by the FDA?
Modified Sonicator 720, Model ME720 (K880602) received a 510(k) decision of Substantially Equivalent on February 25, 1988, 14 days after the submission was received.
What is the product code of K880602?
The FDA product code is IMI – Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat, a Class II (moderate risk) device regulated under 21 CFR 890.5300.