Vasoscreen Impedance Plethysmograph
FDA 510(k) K851102 · Sonicaid, Inc.
510(k) numberK851102
Submission
- Device name
- Vasoscreen Impedance Plethysmograph
- Applicant
- Sonicaid, Inc.
Fredericksburg, VA, US - Received
- March 19, 1985
- Decision date
- May 16, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DQB – Phlebograph, Impedance
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2750
- Specialty
- Cardiovascular
Other 510(k)s with product code DQB
More from Dynatech Research & Development Co.
| 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 |
| 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 |
| K831371 | Model FM5HGM · Traditional | 06/30/1983SE |
Questions and answers
When was Vasoscreen Impedance Plethysmograph cleared by the FDA?
Vasoscreen Impedance Plethysmograph (K851102) received a 510(k) decision of Substantially Equivalent on May 16, 1985, 58 days after the submission was received.
What is the product code of K851102?
The FDA product code is DQB – Phlebograph, Impedance, a Class II (moderate risk) device regulated under 21 CFR 870.2750.