Pyramis ECG Management System Model Numbers, 92600 and 92601
FDA 510(k) K032038 · Quinton, Inc.
510(k) numberK032038
Submission
- Device name
- Pyramis ECG Management System Model Numbers, 92600 and 92601
- Applicant
- Quinton, Inc.
Bothell, WA, US - Received
- July 1, 2003
- Decision date
- September 5, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQK – Computer, Diagnostic, Programmable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1425
- Specialty
- Cardiovascular
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| K992908 | Q-Tel Telemetry System V. 6.0 (ST)DSI · Traditional | 03/06/2000SE |
| K990866 | Quinton Medtrack CR Plus TreadmillISD · Traditional | 04/29/1999SE |
| K971397 | Viewcath 3-D Catheter PullbackITX · Traditional | 08/25/1997SE |
| K964784 | Synergy Cardiology Information System (00431)DPS · Traditional | 08/13/1997SE |
| K964978 | Vital Statistics System (O-Cath Accessory)DQA · Traditional | 05/21/1997SE |
| K955002 | Mahurkar 8 FR Dual Lemen CatheterMPB · Traditional | 09/13/1996SE |
| K961014 | Quinton Model Q710 Exercise and Resting ElectrocardiographLOS · Traditional | 07/31/1996SE |
Questions and answers
When was Pyramis ECG Management System Model Numbers, 92600 and 92601 cleared by the FDA?
Pyramis ECG Management System Model Numbers, 92600 and 92601 (K032038) received a 510(k) decision of Substantially Equivalent on September 5, 2003, 66 days after the submission was received.
What is the product code of K032038?
The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.