NIC-200 VENTRICULAR FUNCTION ANALYZER
FDA 510(k) clearance K792466 · decided 1980-01-24
Clearance details
- K-number
- K792466
- Device name
- NIC-200 VENTRICULAR FUNCTION ANALYZER
- Applicant
- Nicolet Biomedical Instruments
- Decision
- Substantially Equivalent
- Date received
- 1979-12-03
- Decision date
- 1980-01-24
- Days to decision
- 52 days
- Clearance type
- Traditional
- Product code
- DQC
- Device class
- 1
- Regulation number
- 870.2390
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CARDIOPHONICS INCORPORATED DPS 2000 PHONOCARDIOGRAPH (K950537) | Cardiophonics, Inc. | 1996-03-01 |
| LIFE SOUND SENSOR (K952651) | Flowscan, Inc. | 1995-09-19 |
| ACOUSTIC RECORDER (K943726) | Technology Applications Assoc., Inc. | 1994-11-30 |
| PHONOCARDIOGRAPH (K924054) | Echo Ultrasound | 1993-01-22 |
| DYNAMIC SPECTRAL PHONOCARDIOGRAPH (K902185) | Reeves Scientific, Inc. | 1991-03-25 |
| ACUSON HEARTSOUND/PULSE/RESPIRATION MODULE (K900560) | Acuson Corp. | 1990-12-03 |
| PAG MICROPROCESSOR-CONTROLLED MODULE (K900365) | Life Sciences Manufacturing, Inc. | 1990-07-18 |
| MODIFIED DSP100 AMPLIFIER (K873640) | Intl. Acoustics, Inc. | 1987-12-07 |
| ANDRIES PHYSICAL ASSESSMENT COMPUTER (K870545) | Andries Tek, Inc. | 1987-08-14 |
| DSP100 CAROTID PHONOANGIOGRAPHY MODULE (K864429) | Intl. Acoustics, Inc. | 1987-05-12 |
| DSP100 AMPLIFIER (K860814) | Intl. Acoustics, Inc. | 1986-12-05 |
| NON-INVASIVE CLINICAL VASCULAR LAB (K832679) | Life Sciences Manufacturing, Inc. | 1984-01-03 |
Recalls involving this device
No recalls on record reference this clearance.