Morse Anesthesia Manifold
FDA 510(k) K921322 · Namic
510(k) numberK921322
Submission
- Device name
- Morse Anesthesia Manifold
- Applicant
- Namic
Glens Falls, NY, US - Received
- March 12, 1992
- Decision date
- July 9, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FPA – Set, Administration, Intravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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More from B.Braun Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K953676 | Breeze Digital Inflation DeviceMAV · Traditional | 03/29/1996SE |
| K951722 | Perceptor Compensator Morse ManifoldDRS · Traditional | 03/25/1996SE |
| 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 Morse Anesthesia Manifold cleared by the FDA?
Morse Anesthesia Manifold (K921322) received a 510(k) decision of Substantially Equivalent on July 9, 1993, 484 days after the submission was received.
What is the product code of K921322?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.