Reusable Finger Sensor 3444
FDA 510(k) K974697 · Bci Intl., Inc.
510(k) numberK974697
Submission
- Device name
- Reusable Finger Sensor 3444
- Applicant
- Bci Intl., Inc.
Waukesha, WI, US - Received
- December 16, 1997
- Decision date
- March 11, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQH – Cardiograph, Apex (Vibrocardiograph)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2310
- Specialty
- Cardiovascular
More from Bci Intl., Inc.
| 510(k) | Device | Decision |
|---|---|---|
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| K984618 | Bci Mini-Torr Plus, Model 6004DXN · Traditional | 03/25/1999SE |
| K983796 | 6004 Nibp Monitor with TemperatureDXN · Traditional | 01/22/1999SE |
| K982279 | Vital Signs Monitor; Advisor Model # Bci 9200MHX · Traditional | 09/25/1998SE |
| K981939 | Autocorr Plus; 3404 Oximeter/Ecg MonitorDQA · Traditional | 08/20/1998SE |
| K980714 | Bci 3401 Handheld Pulse OximeterDQA · Traditional | 03/25/1998SE |
| K970801 | Bci Model 6004 Nibp Monitor (6004)DXN · Traditional | 11/12/1997SE |
| K970209 | Capnocheck PlusCCK · Traditional | 04/18/1997SE |
| K963496 | Oxi TempDQA · Traditional | 11/26/1996SE |
Questions and answers
When was Reusable Finger Sensor 3444 cleared by the FDA?
Reusable Finger Sensor 3444 (K974697) received a 510(k) decision of Substantially Equivalent on March 11, 1998, 85 days after the submission was received.
What is the product code of K974697?
The FDA product code is DQH – Cardiograph, Apex (Vibrocardiograph), a Class II (moderate risk) device regulated under 21 CFR 870.2310.