LASER - 1000— 510(k) K882436
Substantially EquivalentPanoramic Corp.
FDA 510(k) clearance K882436 for LASER - 1000, Substantially Equivalent on 1988-08-04. Applicant: Panoramic Corp.. Device class: 2.
Clearance details
- Applicant
- Panoramic Corp.
- Product code
- Code EHD
- Device class
- Class 2
- Regulation
- 21 CFR 872.1800
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ft. Wayne, IN, US
Recent devices under product code EHD
view allMore clearances from Panoramic Corp.
view allRecalls naming K882436
K-number listed on FDA's recall record- Z-0517-2018 — PC-1000, PC-1000/Laser1000, Model Numbers 800724-2 & 800724-3
- Z-0016-2017 — Panoramic X-ray Model PC-1000, Laser-1000 packed in a crate Product Usage: The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser1000 will enable the user to take panoramic x-ray images as well as cephalometric x-ray images.
- Z-2538-2015 — Panoramic X-ray Model PC-1000 The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser 1000 will enable the user to take panoramic x-ray images as well as cephalometric x-ray images.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K882436.
Data sourced from openFDA. This site is unofficial and independent of the FDA.