510(k) K811626
- Device
- MEDDARS/ULTRA IMAGER PULSE/PHON MODULE
- Applicant
- HONEYWELL, INC.
- 510(k) number
- K811626
- Product code
- DQC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-07-01
- Date received
- 1981-06-09
- Regulation
- 870.2390
- Classification name
- Phonocardiograph
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3017829091
- 3030035930
- 3031841433
- 3042272797
- 3034603436
- 1054713
- 3031158
- 3016442138
- 3011651230
- 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 |
| K900560 | ACUSON HEARTSOUND/PULSE/RESPIRATION MODULE | Acuson Corp. | 1990-12-03 |
| 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 |
| 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 |
| K770757 | PULSE/PHONOCARDIOGRAPHY CHANNEL, 144 | Honeywell, Inc. | 1977-05-09 |
Legacy Summary#
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FDA Review#
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