Ultra SX
FDA 510(k) K923076 · Excel Tech. , Ltd.
510(k) numberK923076
Submission
- Device name
- Ultra SX
- Applicant
- Excel Tech. , Ltd.
Oakville,Ontario, CA - Received
- June 25, 1992
- Decision date
- March 9, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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| K042223 | Xltek Connex Ip Headbox, Model 1054OMB · Special | 09/16/2004SE |
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Questions and answers
When was Ultra SX cleared by the FDA?
Ultra SX (K923076) received a 510(k) decision of Substantially Equivalent on March 9, 1993, 257 days after the submission was received.
What is the product code of K923076?
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.