Telescope 4MM, 2.7MM Diam. Wide Angle 0', 30', 70', 4MM, Diam, 30' Work, L 14CM, Autoclavable
FDA 510(k) K953888 · Vista Medical Technologies, Inc.
510(k) numberK953888
Submission
- Device name
- Telescope 4MM, 2.7MM Diam. Wide Angle 0', 30', 70', 4MM, Diam, 30' Work, L 14CM, Autoclavable
- Applicant
- Vista Medical Technologies, Inc.
Oceanside, CA, US - Received
- August 17, 1995
- Decision date
- October 7, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- EOB – Nasopharyngoscope (Flexible Or Rigid)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4760
- Specialty
- Ear, Nose, Throat
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 Telescope 4MM, 2.7MM Diam. Wide Angle 0', 30', 70', 4MM, Diam, 30' Work, L 14CM, Autoclavable cleared by the FDA?
Telescope 4MM, 2.7MM Diam. Wide Angle 0', 30', 70', 4MM, Diam, 30' Work, L 14CM, Autoclavable (K953888) received a 510(k) decision of Substantially Equivalent on October 7, 1995, 51 days after the submission was received.
What is the product code of K953888?
The FDA product code is EOB – Nasopharyngoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4760.