Fetal Pulse Detector Model DOP-1
FDA 510(k) K902190 · Advanced Medical Systems, Inc.
510(k) numberK902190
Submission
- Device name
- Fetal Pulse Detector Model DOP-1
- Applicant
- Advanced Medical Systems, Inc.
Hamden, CT, US - Received
- May 16, 1990
- Decision date
- October 22, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HEK – Monitor, Heart Sound, Fetal, Ultrasonic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.2660
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HEK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K142769 | Fetal DopplerHEK · Traditional | Icare Newlife Technologies, Inc. | 03/20/2015SE |
| K060410 | Echoheart Transvaginal Doppler ProbeHEK · Traditional | Summit Doppler Systems, Inc. | 04/10/2006SE |
| K883334 | Biodop(Tm)HEK · Traditional | Diagnosis Related Systems, Inc. | 12/15/1988SE |
| K771211 | Doppler (UTD-5 & UTD-6)HEK · Traditional | Terumo America, Inc. | 07/14/1977SE |
More from Terumo America, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K955931 | Model IM77 Intrapartum Fetal Monitor (Modification)HGM · Traditional | 08/14/1996SE |
| K952031 | Ultrasound Transducer, Model US917HGL · Traditional | 07/18/1995SE |
| K940898 | Model IM77 Intrapartum Fetal MonitorHGM · Traditional | 03/01/1995SE |
| K923335 | Ultrasound Transucer, Model US915 -- ModificationHGL · Traditional | 07/22/1994SE |
| K932278 | PFM Professional 7000 SpirometerBTY · Traditional | 12/17/1993SE |
| K911657 | Fetal Scalp Spiral ElectrodeHGP · Traditional | 07/11/1991SE |
| K894568 | New RAD-8 Treatment Planning Computer SystemKPQ · Traditional | 01/09/1990SE |
| K891672 | Pul-Tron 100K Professional SpirometerBZG · Traditional | 06/16/1989SE |
| K880756 | Model PM-20A Physiological MonitorDQA · Traditional | 09/27/1988SE |
Questions and answers
When was Fetal Pulse Detector Model DOP-1 cleared by the FDA?
Fetal Pulse Detector Model DOP-1 (K902190) received a 510(k) decision of Substantially Equivalent on October 22, 1990, 159 days after the submission was received.
What is the product code of K902190?
The FDA product code is HEK – Monitor, Heart Sound, Fetal, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 884.2660.