The Perceptor(Tm) Stand Alone Transducer
FDA 510(k) K910764 · North American Instrument Corp.
510(k) numberK910764
Submission
- Device name
- The Perceptor(Tm) Stand Alone Transducer
- Applicant
- North American Instrument Corp.
Glens Falls, NY, US - Received
- January 31, 1991
- Decision date
- April 22, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| K960310 | Epic Introducer SheathDYB · Traditional | 02/07/1996SE |
| K922552 | Morse(R) Angiographic CathetersDQO · Traditional | 03/03/1993SE |
| K915078 | Morse Hemostatic Catheter Introducer SetDYB · Traditional | 06/10/1992SE |
| K905208 | Morse AnesthesiaFPA · Traditional | 01/10/1992SE |
| K912961 | Morse Vascular Introducer SetDYB · Traditional | 09/11/1991SE |
| K903493 | Namic Contrast Savings Delivery SystemIZI · Traditional | 03/26/1991SE |
| K904275 | Morse Balloon Inflation DeviceMAV · Traditional | 01/03/1991SE |
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Questions and answers
When was The Perceptor(Tm) Stand Alone Transducer cleared by the FDA?
The Perceptor(Tm) Stand Alone Transducer (K910764) received a 510(k) decision of Substantially Equivalent on April 22, 1991, 81 days after the submission was received.
What is the product code of K910764?
The FDA product code is DRS – Transducer, Blood-Pressure, Extravascular, a Class II (moderate risk) device regulated under 21 CFR 870.2850.