Cardiolab Amplifier Module (Cam)
FDA 510(k) K910307 · Prucka Engineering, Inc.
510(k) numberK910307
Submission
- Device name
- Cardiolab Amplifier Module (Cam)
- Applicant
- Prucka Engineering, Inc.
Houston, TX, US - Received
- January 24, 1991
- Decision date
- April 12, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DRR – Amplifier And Signal Conditioner, Biopotential
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2050
- Specialty
- Cardiovascular
Other 510(k)s with product code DRR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K022660 | Biocheck Myoglobin Elisa, Model BC-1117DRR · Traditional | Biocheck, Inc. | 12/19/2002SE |
| K971570 | Epxpress System (Timberwolf Revision) /000391DRR · Traditional | Quinton Electrophysiology Corp. | 12/29/1997SE |
| K925346 | Ep Amp, Model #901DRR · Traditional | Quinton Electrophysiology Corp. | 04/30/1993SE |
| K914381 | Horizon 9000/HIS Option AmplifierDRR · Traditional | Mennen Medical, Inc. | 01/28/1992SE |
| K911935 | Cardiac Electrophysical Lead Selector, ModifiedDRR · Traditional | Gould, Inc. | 07/22/1991SE |
| K894735 | ASC-952 Physiological AmplifierDRR · Traditional | Astro-Med, Inc. | 09/18/1989SE |
| K894161 | ASC-950 ECG AmplifierDRR · Traditional | Astro-Med, Inc. | 08/03/1989SE |
| K874441 | Bard Biopotential AmplifierDRR · Traditional | C.R. Bard, Inc. | 01/19/1988SE |
| K853652 | BERS-400A Electrophysiological Amplifiers & InputDRR · Traditional | Fisher Imaging Corp. | 01/16/1986SE |
| K813123 | Epc FilterDRR · Traditional | Codman & Shurtleff, Inc. | 11/27/1981SE |
More from Codman & Shurtleff, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K993414 | Prucka Engineering Inc. Cardiolab Ep System,Version 4.2DPS · Traditional | 04/07/2000SE |
| K960321 | Cardiocath Catheterization Lab SystemDPS · Traditional | 08/21/1996SE |
| K904747 | Pei Plaque Electrode ArrayDRF · Traditional | 10/09/1991SE |
| K902716 | Pe Electrophysiology Lab System (Peep)DQK · Traditional | 09/04/1990SE |
| K895916 | Pe Intercardiac Mapping System (Icms)DRF · Traditional | 12/13/1989SE |
Questions and answers
When was Cardiolab Amplifier Module (Cam) cleared by the FDA?
Cardiolab Amplifier Module (Cam) (K910307) received a 510(k) decision of Substantially Equivalent on April 12, 1991, 78 days after the submission was received.
What is the product code of K910307?
The FDA product code is DRR – Amplifier And Signal Conditioner, Biopotential, a Class II (moderate risk) device regulated under 21 CFR 870.2050.