Perceptor Compensator Morse Manifold
FDA 510(k) K951722 · Namic
510(k) numberK951722
Submission
- Device name
- Perceptor Compensator Morse Manifold
- Applicant
- Namic
Glens Falls, NY, US - Received
- April 14, 1995
- Decision date
- March 25, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRS – Transducer, Blood-Pressure, Extravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2850
- Specialty
- Cardiovascular
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More from Mirador Biomedical
| 510(k) | Device | Decision |
|---|---|---|
| K953676 | Breeze Digital Inflation DeviceMAV · Traditional | 03/29/1996SE |
| K921322 | Morse Anesthesia ManifoldFPA · Traditional | 07/09/1993SE |
| K822100 | High Pressure Contrast Injection LineDQO · Traditional | 08/24/1982SE |
| K813549 | Continuous Flush DeviceDRS · Traditional | 01/12/1982SE |
| K790083 | Catheter, Arterial LineDQY · Traditional | 01/25/1979SE |
| K790082 | Arterial Extension SetDQO · Traditional | 01/25/1979SE |
| K782095 | Stopcocks, ManifoldsDTL · Traditional | 01/23/1979SE |
Questions and answers
When was Perceptor Compensator Morse Manifold cleared by the FDA?
Perceptor Compensator Morse Manifold (K951722) received a 510(k) decision of Substantially Equivalent on March 25, 1996, 346 days after the submission was received.
What is the product code of K951722?
The FDA product code is DRS – Transducer, Blood-Pressure, Extravascular, a Class II (moderate risk) device regulated under 21 CFR 870.2850.