Model 118 Pulse Megason
FDA 510(k) K800632 · Birtcher Corp.
510(k) numberK800632
Submission
- Device name
- Model 118 Pulse Megason
- Applicant
- Birtcher Corp.
Walker, MI, US - Received
- March 20, 1980
- Decision date
- May 2, 1980
- 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 Model 118 Pulse Megason cleared by the FDA?
Model 118 Pulse Megason (K800632) received a 510(k) decision of Substantially Equivalent on May 2, 1980, 43 days after the submission was received.
What is the product code of K800632?
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.