Shortwave Diathermy Model 802
FDA 510(k) K780755 · Birtcher Corp.
510(k) numberK780755
Submission
- Device name
- Shortwave Diathermy Model 802
- Applicant
- Birtcher Corp.
Mchenry, IL, US - Received
- May 8, 1978
- Decision date
- May 12, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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Questions and answers
When was Shortwave Diathermy Model 802 cleared by the FDA?
Shortwave Diathermy Model 802 (K780755) received a 510(k) decision of Substantially Equivalent on May 12, 1978, 4 days after the submission was received.
What is the product code of K780755?
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.