ISIS MER SYSTEM/ELEKTA MER SYSTEM— 510(k) K042208
Substantially EquivalentInomed Medizintechnik GmbH
FDA 510(k) clearance K042208 for ISIS MER SYSTEM/ELEKTA MER SYSTEM, Substantially Equivalent on 2005-03-18. Applicant: Inomed Medizintechnik GmbH. Device class: 2.
Clearance details
- Applicant
- Inomed Medizintechnik GmbH
- Product code
- Code GZL
- Device class
- Class 2
- Regulation
- 21 CFR 882.1330
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stockholm, DE
Recent devices under product code GZL
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- K212166 — ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress
Data sourced from openFDA. This site is unofficial and independent of the FDA.