AP-1 Auto Programmer
FDA 510(k) K792590 · Burdick Corp.
510(k) numberK792590
Submission
- Device name
- AP-1 Auto Programmer
- Applicant
- Burdick Corp.
Mchenry, IL, US - Received
- December 17, 1979
- Decision date
- January 4, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- IOL – Treadmill, Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.5380
- Specialty
- Physical Medicine
Other 510(k)s with product code IOL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K950377 | Parker Model PeIOL · Traditional | Parker Treadmill Co., Inc. | 09/06/1995SE |
| K950376 | Parker Model PMIOL · Traditional | Parker Treadmill Co., Inc. | 09/06/1995SE |
| K925839 | TrackmasterIOL · Traditional | Jas Manufacturing Co., Inc. | 06/24/1993SE |
| K930261 | RTM Rehabilitation Treadmill, Model #945-200IOL · Traditional | Biodan Medical Systems, Ltd. | 05/26/1993SE |
| K904556 | Mansfield Cardiac Assist Model 940(TM) IabIOL · Traditional | Boston Scientific Corp | 12/18/1991SE |
| K913518 | TA620 Treadmill ControllerIOL · Traditional | Siemens Burdick, Inc. | 10/24/1991SE |
| K910867 | T600 TreadmillIOL · Traditional | Siemens Burdick, Inc. | 05/31/1991SE |
| K911751 | Medtrack TreadmillIOL · Traditional | Quinton, Inc. | 05/29/1991SE |
| K897179 | Orbiter(Tm) TreadmillIOL · Traditional | Lee-Meredith Industries, Inc. | 02/15/1990SE |
| K895104 | Aquatrex Underwater Treadmill SystemIOL · Traditional | Edmonds Medical Systems | 12/04/1989SE |
More from Edmonds Medical Systems
| 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 AP-1 Auto Programmer cleared by the FDA?
AP-1 Auto Programmer (K792590) received a 510(k) decision of Substantially Equivalent on January 4, 1980, 18 days after the submission was received.
What is the product code of K792590?
The FDA product code is IOL – Treadmill, Powered, a Class I (low risk) device regulated under 21 CFR 890.5380.