HMT Endoscreen, Model Esc 501
FDA 510(k) K942155 · Servicetrends, Inc.
510(k) numberK942155
Submission
- Device name
- HMT Endoscreen, Model Esc 501
- Applicant
- Servicetrends, Inc.
Kennesaw, GA, US - Received
- May 3, 1994
- Decision date
- July 1, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FCW – Light Source, Fiberoptic, Routine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was HMT Endoscreen, Model Esc 501 cleared by the FDA?
HMT Endoscreen, Model Esc 501 (K942155) received a 510(k) decision of Substantially Equivalent on July 1, 1994, 59 days after the submission was received.
What is the product code of K942155?
The FDA product code is FCW – Light Source, Fiberoptic, Routine, a Class II (moderate risk) device regulated under 21 CFR 876.1500.