Neoprobe Model 1500 Portable Radioisotope Detector and Accessories
FDA 510(k) K971167 · Neoprobe Corp.
510(k) numberK971167
Submission
- Device name
- Neoprobe Model 1500 Portable Radioisotope Detector and Accessories
- Applicant
- Neoprobe Corp.
Dublin, OH, US - Received
- March 31, 1997
- Decision date
- June 26, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K962319 | Neoprobe 1000 Gen 1C Portable Radioisotope Detector & AccessoriesIZD · Traditional | Neoprobe Corp. | 09/13/1996SE |
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| K932153 | Thyroid Uptake System & Atomlab 950 Med. SpectromeIZD · Traditional | Biodan Medical Systems, Ltd. | 09/07/1993SE |
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 |
| K962319 | Neoprobe 1000 Gen 1C Portable Radioisotope Detector & AccessoriesIZD · Traditional | 09/13/1996SE |
| 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 Model 1500 Portable Radioisotope Detector and Accessories cleared by the FDA?
Neoprobe Model 1500 Portable Radioisotope Detector and Accessories (K971167) received a 510(k) decision of Substantially Equivalent on June 26, 1997, 87 days after the submission was received.
What is the product code of K971167?
The FDA product code is IZD – Probe, Uptake, Nuclear, a Class I (low risk) device regulated under 21 CFR 892.1320.