PG471W , PG471/50W, PG474W, PG477W, PG479/32W, PG479/50W, PG479/75W Fiab Disposable Electrodes with Cable for Electro-St
FDA 510(k) K091163 · Fiab Spa
510(k) numberK091163
Submission
- Device name
- PG471W , PG471/50W, PG474W, PG477W, PG479/32W, PG479/50W, PG479/75W Fiab Disposable Electrodes with Cable for Electro-St
- Applicant
- Fiab Spa
Firenze, IT - Received
- April 22, 2009
- Decision date
- July 22, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was PG471W , PG471/50W, PG474W, PG477W, PG479/32W, PG479/50W, PG479/75W Fiab Disposable Electrodes with Cable for Electro-St cleared by the FDA?
PG471W , PG471/50W, PG474W, PG477W, PG479/32W, PG479/50W, PG479/75W Fiab Disposable Electrodes with Cable for Electro-St (K091163) received a 510(k) decision of Substantially Equivalent on July 22, 2009, 91 days after the submission was received.
What is the product code of K091163?
The FDA product code is GXY – Electrode, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 882.1320.