Wall Transformers 74710 & 74910
FDA 510(k) K771864 · Welch Allyn, Inc.
510(k) numberK771864
Submission
- Device name
- Wall Transformers 74710 & 74910
- Applicant
- Welch Allyn, Inc.
Mchenry, IL, US - Received
- October 3, 1977
- Decision date
- November 22, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GCW – Transformer, Endoscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was Wall Transformers 74710 & 74910 cleared by the FDA?
Wall Transformers 74710 & 74910 (K771864) received a 510(k) decision of Substantially Equivalent on November 22, 1977, 50 days after the submission was received.
What is the product code of K771864?
The FDA product code is GCW – Transformer, Endoscope, a Class II (moderate risk) device regulated under 21 CFR 876.1500.