Welch Allyn Reveal Intraoral Camera System
FDA 510(k) K981937 · Welch Allyn, Inc.
510(k) numberK981937
Submission
- Device name
- Welch Allyn Reveal Intraoral Camera System
- Applicant
- Welch Allyn, Inc.
Skaneateles Falls, NY, US - Received
- June 2, 1998
- Decision date
- August 24, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Welch Allyn Reveal Intraoral Camera System cleared by the FDA?
Welch Allyn Reveal Intraoral Camera System (K981937) received a 510(k) decision of Substantially Equivalent on August 24, 1998, 83 days after the submission was received.
What is the product code of K981937?
The FDA product code is EIA – Unit, Operative Dental, a Class I (low risk) device regulated under 21 CFR 872.6640.