# GZO: Device, Galvanic Skin Response Measurement

- Device class: 2; regulation: 21 CFR 882.1540; FDA's rule: 510(k) exempt
- FDA decisions: 26
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2000: 2
- 2001: 2
- 2002: 5
- 2003: 2
- 2006: 1
- 2010: 2
- 2011: 1
- 2013: 1
- 2014: 1
- 2015: 2

## Most-cited predicates
- K100233: Sudoscan (2010), cited by 3
- K141872: Sudoscan (2014), cited by 1
- K131568: Sudo Path (2013), cited by 1
- K102166: Electro Interstitial Scan (2010), cited by 1
- K874850: Epi-Scan Selective Tissue Conductance Meter (1988), cited by 1
- K943101: Galvanic Skin Response Device (1995), cited by 1
- K032935: Epi-Scan, Model P 100 (2003), cited by 1

Source page: https://510kreport.com/product-code/GZO
Data by year (CSV): https://510kreport.com/product-code/GZO.csv