PC Holter Scanning System Simplicity, Altair 8200, 8300, 8400
FDA 510(k) K945985 · Burdick, Inc.
510(k) numberK945985
Submission
- Device name
- PC Holter Scanning System Simplicity, Altair 8200, 8300, 8400
- Applicant
- Burdick, Inc.
Miltoon, WI, US - Received
- December 8, 1994
- Decision date
- July 3, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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| K943959 | Eclipse 4 ElectrocardiographLOS · Traditional | 05/17/1995SE |
| K942565 | Altair-Disc RecorderDQK · Traditional | 12/05/1994SE |
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| K942438 | Altair 6100 Cassette RecorderDSH · Traditional | 08/05/1994SE |
| K904032 | Elite II ElectrocardiographLOS · Traditional | 07/24/1991SE |
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| K900729 | Neoserv 824MCJ · Traditional | 06/08/1990SE |
Questions and answers
When was PC Holter Scanning System Simplicity, Altair 8200, 8300, 8400 cleared by the FDA?
PC Holter Scanning System Simplicity, Altair 8200, 8300, 8400 (K945985) received a 510(k) decision of Substantially Equivalent on July 3, 1995, 207 days after the submission was received.
What is the product code of K945985?
The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.