510(k) K900560
- Device
- ACUSON HEARTSOUND/PULSE/RESPIRATION MODULE
- Applicant
- ACUSON CORP.
- 510(k) number
- K900560
- Product code
- DQC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-12-03
- Date received
- 1990-02-07
- Regulation
- 870.2390
- Classification name
- Phonocardiograph
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- T JOHNSON
- Address
- 1220 Charleston Rd. Mountain View CA US 94039 94039
FDA Registration Numbers#
- 3011651230
- 3031158
- 3034603436
- 3030035930
- 3031841433
- 3042272797
- 1054713
- 3017829091
- 3016442138
- 3009607734
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DQC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K950537 | CARDIOPHONICS INCORPORATED DPS 2000 PHONOCARDIOGRAPH | Cardiophonics, Inc. | 1996-03-01 |
| K952651 | LIFE SOUND SENSOR | Flowscan, Inc. | 1995-09-19 |
| K943726 | ACOUSTIC RECORDER | Technology Applications Assoc., Inc. | 1994-11-30 |
| K924054 | PHONOCARDIOGRAPH | Echo Ultrasound | 1993-01-22 |
| K902185 | DYNAMIC SPECTRAL PHONOCARDIOGRAPH | Reeves Scientific, Inc. | 1991-03-25 |
| K900365 | PAG MICROPROCESSOR-CONTROLLED MODULE | Life Sciences Manufacturing, Inc. | 1990-07-18 |
| K873640 | MODIFIED DSP100 AMPLIFIER | Intl. Acoustics, Inc. | 1987-12-07 |
| K870545 | ANDRIES PHYSICAL ASSESSMENT COMPUTER | Andries Tek, Inc. | 1987-08-14 |
| K864429 | DSP100 CAROTID PHONOANGIOGRAPHY MODULE | Intl. Acoustics, Inc. | 1987-05-12 |
| K860814 | DSP100 AMPLIFIER | Intl. Acoustics, Inc. | 1986-12-05 |
| K832679 | NON-INVASIVE CLINICAL VASCULAR LAB | Life Sciences Manufacturing, Inc. | 1984-01-03 |
| K811626 | MEDDARS/ULTRA IMAGER PULSE/PHON MODULE | Honeywell, Inc. | 1981-07-01 |
| K800655 | MODEL 100 SPECTRAVIEW | Edwards Laboratories | 1980-04-16 |
| K792466 | NIC-200 VENTRICULAR FUNCTION ANALYZER | Nicolet Biomedical Instruments | 1980-01-24 |
| K780116 | AMPLIFIER, PC-700 | Burdick Corp. | 1978-02-24 |
Legacy Summary#
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FDA Review#
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