LOOP ELECTRODE, BALL ELECTRODE— 510(k) K993527
Substantially EquivalentPalm Medical USA, Inc.
FDA 510(k) clearance K993527 for LOOP ELECTRODE, BALL ELECTRODE, Substantially Equivalent on 2000-07-06. Applicant: Palm Medical USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Palm Medical USA, Inc.
- Product code
- Code HGI
- Device class
- Class 2
- Regulation
- 21 CFR 884.4120
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gainesville, FL, US
Recent devices under product code HGI
view allAdverse events under product code HGI
product code HGI- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.