Aneroid Blood Pressure Gauge
FDA 510(k) K904376 · Biomedical Dynamics, Inc.
510(k) numberK904376
Submission
- Device name
- Aneroid Blood Pressure Gauge
- Applicant
- Biomedical Dynamics, Inc.
Burnsville, MN, US - Received
- September 25, 1990
- Decision date
- December 20, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FCY – Bulb, Inflation, For Endoscope
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
An endoscope bulb pressurizes the interior of an endoscope. The user identifies the presence of leaks in the endoscope by immersing in water and visually observing for bubbles.
Other 510(k)s with product code FCY
More from CIVCO Medical Instruments Co., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K915074 | Irrigator/Aspirator ProbeHMX · Traditional | 02/05/1992SE |
| K913751 | Pressure InfuserKZD · Traditional | 01/09/1992SE |
| K911213 | CuffableDXQ · Traditional | 08/07/1991SE |
| K911216 | InfusableKZD · Traditional | 07/22/1991SE |
| K911324 | Irrigation/Aspiration Tubing SetKDH · Traditional | 06/24/1991SE |
| K890268 | Pressure Infusor for I.V. Bags/AutoinflationKPE · Traditional | 05/05/1989SE |
| K881799 | Blood Pressure CuffDXQ · Traditional | 10/14/1988SE |
| K861977 | Biomedical Dynamics Disposable Pressure InfusorKZD · Traditional | 07/15/1986SE |
| K850506 | Correct Flo Intravascular Administration SetFPA · Traditional | 04/01/1985SE |
Questions and answers
When was Aneroid Blood Pressure Gauge cleared by the FDA?
Aneroid Blood Pressure Gauge (K904376) received a 510(k) decision of Substantially Equivalent on December 20, 1990, 86 days after the submission was received.
What is the product code of K904376?
The FDA product code is FCY – Bulb, Inflation, For Endoscope, a Class I (low risk) device regulated under 21 CFR 876.1500.