Single Channel Nonfade Oscilloscope
FDA 510(k) K822517 · Quinton, Inc.
510(k) numberK822517
Submission
- Device name
- Single Channel Nonfade Oscilloscope
- Applicant
- Quinton, Inc.
Mchenry, IL, US - Received
- August 20, 1982
- Decision date
- September 14, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXJ – Display, Cathode-Ray Tube, Medical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2450
- Specialty
- Cardiovascular
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| K971397 | Viewcath 3-D Catheter PullbackITX · Traditional | 08/25/1997SE |
| K964784 | Synergy Cardiology Information System (00431)DPS · Traditional | 08/13/1997SE |
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Questions and answers
When was Single Channel Nonfade Oscilloscope cleared by the FDA?
Single Channel Nonfade Oscilloscope (K822517) received a 510(k) decision of Substantially Equivalent on September 14, 1982, 25 days after the submission was received.
What is the product code of K822517?
The FDA product code is DXJ – Display, Cathode-Ray Tube, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2450.