Acmi M4 Telescopes
FDA 510(k) K031758 · Acmi Corporation
510(k) numberK031758
Submission
- Device name
- Acmi M4 Telescopes
- Applicant
- Acmi Corporation
Southborough, MA, US - Received
- June 6, 2003
- Decision date
- September 2, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FBP – Telescope, Rigid, Endoscopic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
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| K984607 | Panoview Plus Optic with 2.7MM Diameter, Model 8672.XXX, Panoview Plus Optic with 1.9MM…FBP · Traditional | Richard Wolf Medical Instruments Corp. | 03/05/1999SE |
| K760177 | Telescope, Rigid EndoscopeFBP · Traditional | V. Mueller O.V. Baxter Healthcare Corp. | 08/30/1976SE |
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Questions and answers
When was Acmi M4 Telescopes cleared by the FDA?
Acmi M4 Telescopes (K031758) received a 510(k) decision of Substantially Equivalent on September 2, 2003, 88 days after the submission was received.
What is the product code of K031758?
The FDA product code is FBP – Telescope, Rigid, Endoscopic, a Class II (moderate risk) device regulated under 21 CFR 876.1500.