Olympus Neuroscope, Models S-1349/1, S-1349/2, S-1349/3 and S-1349/4
FDA 510(k) K020507 · Olympus Winter & Ibe GmbH
510(k) numberK020507
Submission
- Device name
- Olympus Neuroscope, Models S-1349/1, S-1349/2, S-1349/3 and S-1349/4
- Applicant
- Olympus Winter & Ibe GmbH
Melville, NY, US - Received
- February 15, 2002
- Decision date
- October 8, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GWG – Endoscope, Neurological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1480
- Specialty
- Neurology
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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Questions and answers
When was Olympus Neuroscope, Models S-1349/1, S-1349/2, S-1349/3 and S-1349/4 cleared by the FDA?
Olympus Neuroscope, Models S-1349/1, S-1349/2, S-1349/3 and S-1349/4 (K020507) received a 510(k) decision of Substantially Equivalent on October 8, 2002, 235 days after the submission was received.
What is the product code of K020507?
The FDA product code is GWG – Endoscope, Neurological, a Class II (moderate risk) device regulated under 21 CFR 882.1480.