Camino Model M420: Monit Inter W/Mean Pres Display
FDA 510(k) K912833 · Camino Laboratories, Inc.
510(k) numberK912833
Submission
- Device name
- Camino Model M420: Monit Inter W/Mean Pres Display
- Applicant
- Camino Laboratories, Inc.
San Diego, CA, US - Received
- June 26, 1991
- Decision date
- September 23, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DSK – Computer, Blood-Pressure
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1110
- Specialty
- Cardiovascular
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| K920088 | Camino Ventricular NeedleHCD · Traditional | 05/01/1992SE |
| K914735 | Ventricular Pressure Monitoring Kit, Model 110-4HMGWM · Traditional | 01/17/1992SE |
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| K881183 | Ventricular Bolt Pressure Monitoring Kit #110-4HGWM · Traditional | 05/04/1988SE |
| K863969 | Camino Compartmental Press Monitor CATH/110-4DDXO · Traditional | 05/27/1987SE |
| K861961 | Camino CSF Drainage System Model 040JXG · Traditional | 08/12/1986SE |
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Questions and answers
When was Camino Model M420: Monit Inter W/Mean Pres Display cleared by the FDA?
Camino Model M420: Monit Inter W/Mean Pres Display (K912833) received a 510(k) decision of Substantially Equivalent on September 23, 1991, 89 days after the submission was received.
What is the product code of K912833?
The FDA product code is DSK – Computer, Blood-Pressure, a Class II (moderate risk) device regulated under 21 CFR 870.1110.