DRR — Amplifier And Signal Conditioner, Biopotential Class II
FDA product code DRR covers "Amplifier And Signal Conditioner, Biopotential", a Class II medical device regulated under 21 CFR 870.2050. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DRR
- Device Class
- Class II
- Regulation Number
- 870.2050
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K022660 | biocheck | BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117 | December 19, 2002 |
| K971570 | quinton electrophysiology | EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391 | December 29, 1997 |
| K925346 | quinton electrophysiology | EP AMP, MODEL #901 | April 30, 1993 |
| K914381 | mennen medical | HORIZON 9000/HIS OPTION AMPLIFIER | January 28, 1992 |
| K911935 | gould | CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED | July 22, 1991 |
| K910307 | prucka engineering | CARDIOLAB AMPLIFIER MODULE (CAM) | April 12, 1991 |
| K894735 | astro-med | ASC-952 PHYSIOLOGICAL AMPLIFIER | September 18, 1989 |
| K894161 | astro-med | ASC-950 ECG AMPLIFIER | August 3, 1989 |
| K874441 | c.r. bard | BARD BIOPOTENTIAL AMPLIFIER | January 19, 1988 |
| K853652 | fisher imaging | BERS-400A ELECTROPHYSIOLOGICAL AMPLIFIERS & INPUT | January 16, 1986 |
| K813123 | codman and shurtleff | EPC FILTER | November 27, 1981 |
| K810828 | henry ford hospital | NON-INVASIVE AMPLIFIER | April 10, 1981 |
| K802686 | hewlett-packard | HP MODEL 8880A FILTER | November 26, 1980 |
| K802282 | consolidated medical equipment | ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON | October 10, 1980 |
| K792283 | arzbaecher and | ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON | November 21, 1979 |
| K791964 | hewlett-packard | MODEL 15055A MAINFRAME | October 11, 1979 |
| K790203 | electronics for medicine | INTERVAL TIMER MODEL V4295 | March 2, 1979 |
| K780572 | c-v monitors | DCG PREAMPLIFIER MODULE | May 9, 1978 |
| K780043 | datascope | ESIS MODULE | February 13, 1978 |
| K772132 | hewlett-packard | AMPLIFIER MODULE, 78211A ECG | November 22, 1977 |