Ambulatory Monitor AM-1
FDA 510(k) K801001 · Burdick Corp.
510(k) numberK801001
Submission
- Device name
- Ambulatory Monitor AM-1
- Applicant
- Burdick Corp.
Mchenry, IL, US - Received
- April 25, 1980
- Decision date
- May 28, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DSH – Recorder, Magnetic Tape, Medical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2800
- Specialty
- Cardiovascular
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More from Bardy Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K952417 | Quest Exercise Stress SystemDSI · Traditional | 05/22/1996SE |
| K954267 | Burdick 200 Pulse OximeterDQA · Traditional | 05/03/1996SE |
| K946281 | Eclipse 4 ElectrocardiographLOS · Traditional | 04/23/1996SE |
| K945985 | PC Holter Scanning System Simplicity, Altair 8200, 8300, 8400DQK · Traditional | 07/03/1995SE |
| K943959 | Eclipse 4 ElectrocardiographLOS · Traditional | 05/17/1995SE |
| K942565 | Altair-Disc RecorderDQK · Traditional | 12/05/1994SE |
| K941351 | Burdick PRO2 OximeterDQA · Traditional | 10/13/1994SE |
| K942438 | Altair 6100 Cassette RecorderDSH · Traditional | 08/05/1994SE |
| K904032 | Elite II ElectrocardiographLOS · Traditional | 07/24/1991SE |
| K903565 | E560 ElectrocardiographLOS · Traditional | 07/24/1991SE |
Questions and answers
When was Ambulatory Monitor AM-1 cleared by the FDA?
Ambulatory Monitor AM-1 (K801001) received a 510(k) decision of Substantially Equivalent on May 28, 1980, 33 days after the submission was received.
What is the product code of K801001?
The FDA product code is DSH – Recorder, Magnetic Tape, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2800.