Biopak Measurement System
FDA 510(k) K981563 · Bio-Research Associates, Inc.
510(k) numberK981563
Submission
- Device name
- Biopak Measurement System
- Applicant
- Bio-Research Associates, Inc.
Milwaukee, WI, US - Received
- May 1, 1998
- Decision date
- September 15, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KZM – Device, Muscle Monitoring
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.1375
- Specialty
- Physical Medicine
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| K130158 | M-ScanKZM · Traditional | Bio-Research Associates, Inc. | 07/25/2013SE |
| K113677 | Grindcare MeasureKZM · Traditional | Medotech A/S | 04/05/2012SE |
| K082927 | Bioemg IIIKZM · Traditional | Bio-Research Associates, Inc. | 02/06/2009SE |
| K043373 | Dolotens Dental TM 1KZM · Abbreviated | Neuromuscular Technologies, Inc. | 09/02/2005SE |
| K030869 | BitestripKZM · Traditional | S.L.P. , Ltd. | 05/14/2004SE |
| K003176 | Bioemg II and BiojvaKZM · Traditional | Bio-Research Associates, Inc. | 01/04/2001SE |
| K003287 | Model K7 Evaluation DeviceKZM · Special | Myotronics-Noromed, Inc. | 11/06/2000SE |
| K992694 | Modification to K6-I Diagnostic System, Model K6-IKZM · Special | Myotronics-Noromed, Inc. | 09/10/1999SE |
| K944134 | K6-1 Diagnostic System Version 3.1KZM · Traditional | Myo-Tronics, Inc. | 12/09/1994SE |
More from Myo-Tronics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K130158 | M-ScanKZM · Traditional | 07/25/2013SE |
| K082927 | Bioemg IIIKZM · Traditional | 02/06/2009SE |
| K061799 | Quadratens, Model QT-42GZJ · Traditional | 08/28/2006SE |
| K003176 | Bioemg II and BiojvaKZM · Traditional | 01/04/2001SE |
| K991756 | 3 Channel Knee Electronic Amplified StethoscopeDQD · Traditional | 12/10/1999SE |
| K952218 | JT-3 ElectrognathographNFS · Traditional | 09/21/1995SE |
| K873947 | Bio-Emg Model 800KZM · Traditional | 04/27/1988SE |
| K844618 | Bio-TensGZJ · Traditional | 08/21/1985SE |
| K822565 | Needle Catheter Jejunostomy KitKNT · Traditional | 09/28/1982SE |
Questions and answers
When was Biopak Measurement System cleared by the FDA?
Biopak Measurement System (K981563) received a 510(k) decision of Substantially Equivalent on September 15, 1998, 137 days after the submission was received.
What is the product code of K981563?
The FDA product code is KZM – Device, Muscle Monitoring, a Class II (moderate risk) device regulated under 21 CFR 890.1375.