IDA-4 and Ipt-Mc
FDA 510(k) K973609 · Bio-Tek Instruments, Inc.
510(k) numberK973609
Submission
- Device name
- IDA-4 and Ipt-Mc
- Applicant
- Bio-Tek Instruments, Inc.
Winooski, VT, US - Received
- September 22, 1997
- Decision date
- December 18, 1997
- Decision
- Substantially Equivalent - Subject to Tracking Reg. (ST)
- Type
- Traditional 510(k)
Device classification
- Product code
- FRN – Pump, Infusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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| 510(k) | Device | Decision |
|---|---|---|
| K971273 | Index 2E, Index 2F, Index 2EF, Cardiosat 100E, Cardiosat 100F, Cardiosat 100EFDQA · Traditional | 10/08/1997SE |
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| K954391 | Models QED-6, 6M and 6H Defibrillator Analyzer with Optional Universal Pacemaker Load…DRL · Traditional | 11/17/1995SE |
| K953710 | ELX808 Automated Microplate ReadersJJQ · Traditional | 10/25/1995SE |
| K953572 | ELX800UVJJQ · Traditional | 10/19/1995SE |
| K950104 | ELX800 and EL800 Automated Microplate ReadersJJQ · Traditional | 03/21/1995SE |
| K942923 | Ceres 900C & Ceres UV900CJJQ · Traditional | 02/06/1995SE |
| K944257 | Lionheart 3 Multi-Parameter SimulatorDRT · Traditional | 09/21/1994SE |
| K933519 | Index SPO2 SimulatorDQA · Traditional | 09/01/1994SE |
| K933548 | Els 1000JJE · Traditional | 10/29/1993SE |
Questions and answers
When was IDA-4 and Ipt-Mc cleared by the FDA?
IDA-4 and Ipt-Mc (K973609) received a 510(k) decision of Substantially Equivalent - Subject to Tracking Reg. on December 18, 1997, 87 days after the submission was received.
What is the product code of K973609?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.