Cardiac Acquisition System, Icr 2001
FDA 510(k) K770705 · Instruments For Cardiac Research
510(k) numberK770705
Submission
- Device name
- Cardiac Acquisition System, Icr 2001
- Applicant
- Instruments For Cardiac Research
Mchenry, IL, US - Received
- April 18, 1977
- Decision date
- June 2, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| K820011 | CardiostressDPS · Traditional | 01/22/1982SE |
| K812920 | Event MasterDSH · Traditional | 12/02/1981SE |
| K801903 | Series 4000 Stress & Exercise SystemDSI · Traditional | 03/11/1981SE |
| K771374 | Scanner Trend SystemDSI · Traditional | 08/04/1977SE |
Questions and answers
When was Cardiac Acquisition System, Icr 2001 cleared by the FDA?
Cardiac Acquisition System, Icr 2001 (K770705) received a 510(k) decision of Substantially Equivalent on June 2, 1977, 45 days after the submission was received.
What is the product code of K770705?
The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.