510(k) K925346
- Device
- EP AMP, MODEL #901
- Applicant
- QUINTON ELECTROPHYSIOLOGY CORP.
- 510(k) number
- K925346
- Product code
- DRR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-04-30
- Date received
- 1992-10-22
- Regulation
- 870.2050
- Classification name
- Amplifier And Signal Conditioner, Biopotential
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- HAROLD WODLINGER
- Address
- 3075 14th Ave., Suite 6 Markham, Ontario CA L3R 2L6 L3R 2L6
FDA Registration Numbers#
- 1832216
- 1827821
- 3005984081
- 2025099
- 2029372
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DRR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K022660 | BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117 | Biocheck, Inc. | 2002-12-19 |
| K971570 | EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391 | Quinton Electrophysiology Corp. | 1997-12-29 |
| K914381 | HORIZON 9000/HIS OPTION AMPLIFIER | Mennen Medical, Inc. | 1992-01-28 |
| K911935 | CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED | Gould, Inc. | 1991-07-22 |
| K910307 | CARDIOLAB AMPLIFIER MODULE (CAM) | Prucka Engineering, Inc. | 1991-04-12 |
| K894735 | ASC-952 PHYSIOLOGICAL AMPLIFIER | Astro-Med, Inc. | 1989-09-18 |
| K894161 | ASC-950 ECG AMPLIFIER | Astro-Med, Inc. | 1989-08-03 |
| K874441 | BARD BIOPOTENTIAL AMPLIFIER | C.R. Bard, Inc. | 1988-01-19 |
| K853652 | BERS-400A ELECTROPHYSIOLOGICAL AMPLIFIERS & INPUT | Fisher Imaging Corp. | 1986-01-16 |
| K813123 | EPC FILTER | Codman & Shurtleff, Inc. | 1981-11-27 |
| K810828 | NON-INVASIVE AMPLIFIER | Henry Ford Hospital | 1981-04-10 |
| K802686 | HP MODEL 8880A FILTER | Hewlett-Packard Co. | 1980-11-26 |
| K802282 | ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON | Consolidated Medical Equipment, Inc. | 1980-10-10 |
| K792283 | ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON | Arzbaecher & Co. | 1979-11-21 |
| K791964 | MODEL 15055A MAINFRAME | Hewlett-Packard Co. | 1979-10-11 |
Legacy Summary#
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FDA Review#
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