Novametrix 350 Recorder-Paper Chart Recorder
FDA 510(k) K850487 · Novametrix Medical Systems, Inc.
510(k) numberK850487
Submission
- Device name
- Novametrix 350 Recorder-Paper Chart Recorder
- Applicant
- Novametrix Medical Systems, Inc.
Wallingford, CT, US - Received
- February 7, 1985
- Decision date
- March 29, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DSF – Recorder, Paper Chart
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 870.2810
- Specialty
- Cardiovascular
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|---|---|---|---|
| K910871 | Edentec Digital Charter Model 3710DSF · Traditional | Edentec Corp. | 08/29/1991SE |
| K912929 | Dash IVDSF · Traditional | Astro-Med, Inc. | 08/13/1991SE |
| K905856 | Model 556 MonitorDSF · Traditional | Ge Medical Systems Information Technologies | 01/11/1991SE |
| K902586 | Gri Lasergraph(Tm) ECG PaperDSF · Traditional | Gri Medical Products, Inc. | 06/22/1990SE |
| K902230 | Colorado Color Imaging RecorderDSF · Traditional | Honeywell, Inc. | 06/19/1990SE |
| K901385 | Gabriel Medical CLS Thermal RecorderDSF · Traditional | Gabriel Medical, Inc. | 05/09/1990SE |
| K895111 | Type 9541 Recorder, Paper ChartDSF · Traditional | S & W Medico Teknik | 01/26/1990SE |
| K894922 | WR3500 and WR3600 Series RecordersDSF · Traditional | Western Graphtec | 01/26/1990SE |
| K894736 | MT96000 Paper Chart RecorderDSF · Traditional | Astro-Med, Inc. | 12/13/1989SE |
| K894607 | PAQ10 Paper Chart RecorderDSF · Traditional | Protocol Systems, Inc. | 10/26/1989SE |
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| K982499 | Cosmo Plus with Nico, Model 8200BZC · Traditional | 10/16/1998SE |
| K964360 | Vent(Ventcheck) Handheld Respiratory/Mechanics Monitor Model 101BZC · Traditional | 04/04/1997SE |
| 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 |
Questions and answers
When was Novametrix 350 Recorder-Paper Chart Recorder cleared by the FDA?
Novametrix 350 Recorder-Paper Chart Recorder (K850487) received a 510(k) decision of Substantially Equivalent on March 29, 1985, 50 days after the submission was received.
What is the product code of K850487?
The FDA product code is DSF – Recorder, Paper Chart, a Class I (low risk) device regulated under 21 CFR 870.2810.