Neoprobe 1000 Gen 1C Portable Radioisotope Detector & Accessories
FDA 510(k) K962319 · Neoprobe Corp.
510(k) numberK962319
Submission
- Device name
- Neoprobe 1000 Gen 1C Portable Radioisotope Detector & Accessories
- Applicant
- Neoprobe Corp.
Dublin, OH, US - Received
- June 17, 1996
- Decision date
- September 13, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Biodan Medical Systems, Ltd.
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| K050088 | Quantix/Or Blood Flow Monitor; Flexible Probe with Optional Vessel StabilizerDPW · Special | 02/08/2005SE |
| K971167 | Neoprobe Model 1500 Portable Radioisotope Detector and AccessoriesIZD · Traditional | 06/26/1997SE |
| K942580 | Neoprobe 1000 Portable Radioisotope Detector and AccessoriesIZD · Traditional | 02/09/1995SE |
| K915279 | Neoprobe Portable Radioscope DetectorIZD · Traditional | 06/10/1992SE |
| K864263 | Neoprobe Portable Radioisotope DetectorIZD · Traditional | 12/29/1986SE |
Questions and answers
When was Neoprobe 1000 Gen 1C Portable Radioisotope Detector & Accessories cleared by the FDA?
Neoprobe 1000 Gen 1C Portable Radioisotope Detector & Accessories (K962319) received a 510(k) decision of Substantially Equivalent on September 13, 1996, 88 days after the submission was received.
What is the product code of K962319?
The FDA product code is IZD – Probe, Uptake, Nuclear, a Class I (low risk) device regulated under 21 CFR 892.1320.