Megason Model 150
FDA 510(k) K843221 · Birtcher Corp.
510(k) numberK843221
Submission
- Device name
- Megason Model 150
- Applicant
- Birtcher Corp.
Mchenry, IL, US - Received
- August 16, 1984
- Decision date
- August 24, 1984
- 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 Megason Model 150 cleared by the FDA?
Megason Model 150 (K843221) received a 510(k) decision of Substantially Equivalent on August 24, 1984, 8 days after the submission was received.
What is the product code of K843221?
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.