Fetal Monitoring System
FDA 510(k) K780487 · Sonicaid, Inc.
510(k) numberK780487
Submission
- Device name
- Fetal Monitoring System
- Applicant
- Sonicaid, Inc.
- Received
- March 27, 1978
- Decision date
- May 9, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HFO – Recorder, Pressure, Intrauterine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.2700
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HFO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K973850 | Alexander Manufacturing Co. Rechargeable Battery #M007HFO · Traditional | Alexander Mfg. Co. | 11/12/1997SE |
| K943989 | Laparoscopic/Endoscopic InstruementHFO · Traditional | Gabris Surgical Corp. | 09/12/1994SE |
| K791633 | UC-2000 Uterine Catherization SystemHFO · Traditional | Life Support, Inc. | 09/17/1979SE |
More from Life Support, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K873673 | BV105 (&BV105R) Vascular Flow Detector W/OptionalDPT · Traditional | 02/26/1988SE |
| K872074 | 5 MHZ TransducerJOP · Traditional | 08/25/1987SE |
| K863803 | Vasopulse(Tm)/Model 5000JOM · Traditional | 05/06/1987SE |
| K862720 | VASOFLO-3 & Extravascular Blood Flow ProbesDPW · Traditional | 11/17/1986SE |
| K861237 | Vasoview Duplex Imaging SystemITX · Traditional | 07/14/1986SN |
| K851102 | Vasoscreen Impedance PlethysmographDQB · Traditional | 05/16/1985SE |
| K833902 | VasoscanJOP · Traditional | 01/27/1984SE |
| K832374 | Photoflo Dual-Mode PhotoplethysmographJOM · Traditional | 12/01/1983SE |
| K833488 | SonicompHEM · Traditional | 11/28/1983SE |
| K833227 | Sonicaid Model D206E Air Emboli-DetectLBA · Traditional | 10/27/1983SE |
Questions and answers
When was Fetal Monitoring System cleared by the FDA?
Fetal Monitoring System (K780487) received a 510(k) decision of Substantially Equivalent on May 9, 1978, 43 days after the submission was received.
What is the product code of K780487?
The FDA product code is HFO – Recorder, Pressure, Intrauterine, a Class II (moderate risk) device regulated under 21 CFR 884.2700.