Vent(Ventcheck) Handheld Respiratory/Mechanics Monitor Model 101
FDA 510(k) K964360 · Novametrix Medical Systems, Inc.
510(k) numberK964360
Submission
- Device name
- Vent(Ventcheck) Handheld Respiratory/Mechanics Monitor Model 101
- Applicant
- Novametrix Medical Systems, Inc.
Wallingford, CT, US - Received
- November 1, 1996
- Decision date
- April 4, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- BZC – Calculator, Pulmonary Function Data
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1880
- Specialty
- Anesthesiology
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More from Innovision A/S
| 510(k) | Device | Decision |
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| K010451 | Novametrix Marquette Compatible SensorsDQA · Abbreviated | 04/25/2001SE |
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| K993979 | MARSPO2, Model 2001DQA · Abbreviated | 02/22/2000SE |
| K982499 | Cosmo Plus with Nico, Model 8200BZC · Traditional | 10/16/1998SE |
| K963380 | Co 2 Smo PlusBZC · Traditional | 01/22/1997SE |
| K963327 | Tidal Wave Carbon Dioxide Monitor, Model 610CCK · Traditional | 11/20/1996SE |
| K960831 | Ventrak RMMS 1550BZC · Traditional | 05/29/1996SE |
| K924626 | Novametrix Model 510DQA · Traditional | 12/03/1993SE |
| K920379 | Novametrix Model 7100 Comb. End Tidal CO2 & Pul OxDQA · Traditional | 07/15/1992SE |
| K913516 | Model 520A Novametrix Pulse OximeterDQA · Traditional | 11/04/1991SE |
Questions and answers
When was Vent(Ventcheck) Handheld Respiratory/Mechanics Monitor Model 101 cleared by the FDA?
Vent(Ventcheck) Handheld Respiratory/Mechanics Monitor Model 101 (K964360) received a 510(k) decision of Substantially Equivalent on April 4, 1997, 154 days after the submission was received.
What is the product code of K964360?
The FDA product code is BZC – Calculator, Pulmonary Function Data, a Class II (moderate risk) device regulated under 21 CFR 868.1880.