Pulse/Phonocardiography Channel, 144
FDA 510(k) K770757 · Honeywell, Inc.
510(k) numberK770757
Submission
- Device name
- Pulse/Phonocardiography Channel, 144
- Applicant
- Honeywell, Inc.
Mchenry, IL, US - Received
- April 25, 1977
- Decision date
- May 9, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DQC – Phonocardiograph
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 870.2390
- Specialty
- Cardiovascular
Other 510(k)s with product code DQC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K950537 | Cardiophonics Incorporated DPS 2000 PhonocardiographDQC · Traditional | Cardiophonics, Inc. | 03/01/1996SE |
| K952651 | Life Sound SensorDQC · Traditional | Flowscan, Inc. | 09/19/1995SE |
| K943726 | Acoustic RecorderDQC · Traditional | Technology Applications Assoc., Inc. | 11/30/1994SE |
| K924054 | PhonocardiographDQC · Traditional | Echo Ultrasound | 01/22/1993SE |
| K902185 | Dynamic Spectral PhonocardiographDQC · Traditional | Reeves Scientific, Inc. | 03/25/1991SE |
| K900560 | Acuson Heartsound/Pulse/Respiration ModuleDQC · Traditional | Acuson Corp. | 12/03/1990SE |
| K900365 | Pag Microprocessor-Controlled ModuleDQC · Traditional | Life Sciences Manufacturing, Inc. | 07/18/1990SE |
| K873640 | Modified DSP100 AmplifierDQC · Traditional | Intl. Acoustics, Inc. | 12/07/1987SE |
| K870545 | Andries Physical Assessment ComputerDQC · Traditional | Andries Tek, Inc. | 08/14/1987SE |
| K864429 | DSP100 Carotid Phonoangiography ModuleDQC · Traditional | Intl. Acoustics, Inc. | 05/12/1987SE |
More from Intl. Acoustics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K902230 | Colorado Color Imaging RecorderDSF · Traditional | 06/19/1990SE |
| K863100 | Cen Sta Mon Ac/Dc Alarm Central Acces Alarm RecorDPS · Traditional | 02/03/1987SE |
| K853501 | Honeywell Electronic Ventilator Ev-ACBK · Traditional | 04/04/1986SE |
| K855125 | Physiological Telemetry Patient Monitoring SystemDRT · Traditional | 03/26/1986SE |
| K851888 | Apm Dispos. Blood Pressure TransducerDRS · Traditional | 08/06/1985SE |
| K851496 | ECG Monitor Model RM102DXJ · Traditional | 07/24/1985SE |
| K850794 | Patient Monitor Model RM-300DTR · Traditional | 04/18/1985SE |
| K851092 | Portable Defibrillator/Monitor Ed 425LDD · Traditional | 04/10/1985SE |
| K834530 | Extension Box EB200DRT · Traditional | 06/01/1984SE |
| K834282 | Ultra Imager 2000IYO · Traditional | 04/23/1984SE |
Questions and answers
When was Pulse/Phonocardiography Channel, 144 cleared by the FDA?
Pulse/Phonocardiography Channel, 144 (K770757) received a 510(k) decision of Substantially Equivalent on May 9, 1977, 14 days after the submission was received.
What is the product code of K770757?
The FDA product code is DQC – Phonocardiograph, a Class I (low risk) device regulated under 21 CFR 870.2390.