INTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATOR— 510(k) K130549
Substantially EquivalentCarl Zeiss Meditec, Inc.
FDA 510(k) clearance K130549 for INTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATOR, Substantially Equivalent on 2013-06-26. Applicant: Carl Zeiss Meditec, Inc.. Device class: 2.
Clearance details
- Applicant
- Carl Zeiss Meditec, Inc.
- Product code
- Code JAD
- Device class
- Class 2
- Regulation
- 21 CFR 892.5900
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dublin, CA, US
Recent devices under product code JAD
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view allRecalls naming K130549
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K130549.
Data sourced from openFDA. This site is unofficial and independent of the FDA.