CAREDOP II— 510(k) K982635
Substantially EquivalentNicolet Biomedical
FDA 510(k) clearance K982635 for CAREDOP II, Substantially Equivalent on 1998-08-07. Applicant: Nicolet Biomedical. Device class: 2.
Clearance details
- Applicant
- Nicolet Biomedical
- Product code
- Code JAF
- Device class
- Class 2
- Regulation
- 21 CFR 892.1540
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Golden, CO, US
Recent devices under product code JAF
view allMore clearances from Nicolet Biomedical
view allRecalls naming K982635
K-number listed on FDA's recall record- Z-2726-2017 — Nicolet¿ Elite¿ 2 MHz OB Probe, Non-Fetal Monitor, Model #: X1L007, Catalog Code: N200. Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc.
- Z-2727-2017 — Nicolet¿ Elite¿ 2 MHz OB Water Proof Probe, Model #: X1L008, Catalog Code: NW20. Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc.
- Z-2728-2017 — Nicolet¿ Elite¿ 3 MHz OB Probe, Model #: X1L001, Catalog Code: N300. Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc.
- Z-2729-2017 — Nicolet¿ Elite¿ 5 MHz Vascular Probe, Model #: X1L004, Catalog Code: N500. Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K982635.
Data sourced from openFDA. This site is unofficial and independent of the FDA.