510(k) K981563
- Device
- BIOPAK MEASUREMENT SYSTEM
- Applicant
- BIO-RESEARCH ASSOCIATES, INC.
- 510(k) number
- K981563
- Product code
- KZM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-09-15
- Date received
- 1998-05-01
- Regulation
- 890.1375
- Classification name
- Device, Muscle Monitoring
- Medical specialty
- Physical Medicine
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Address
- 4113 N. Port Washington Rd. Milwaukee WI US 53212 53212
FDA Registration Numbers#
- 3005998761
- 3007616088
- 3010399798
- 2183552
- 3014732
- 3007389703
- 2023152
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KZM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K161716 | TEETHAN 2.0 | Bts S.P.A. | 2016-12-21 |
| K130158 | M-SCAN | Bio-Research Associates, Inc. | 2013-07-25 |
| K113677 | GRINDCARE MEASURE | Medotech A/S | 2012-04-05 |
| K082927 | BIOEMG III | Bio-Research Associates, Inc. | 2009-02-06 |
| K043373 | DOLOTENS DENTAL TM 1 | Neuromuscular Technologies, Inc. | 2005-09-02 |
| K030869 | BITESTRIP | S.L.P. , Ltd. | 2004-05-14 |
| K003176 | BIOEMG II AND BIOJVA | Bio-Research Associates, Inc. | 2001-01-04 |
| K003287 | MODEL K7 EVALUATION DEVICE | Myotronics-Noromed, Inc. | 2000-11-06 |
| K992694 | MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I | Myotronics-Noromed, Inc. | 1999-09-10 |
| K944134 | K6-1 DIAGNOSTIC SYSTEM VERSION 3.1 | Myo-Tronics, Inc. | 1994-12-09 |
| K922456 | K6-I DIAGNOSTIC SYSTEM | Myo-Tronics, Inc. | 1994-06-09 |
| K921919 | MS-100 MYO-SCANNER OR MS-100 EMG SCANNER | Myo-Tronics, Inc. | 1993-01-07 |
| K873947 | BIO-EMG MODEL 800 | Bio-Research Associates, Inc. | 1988-04-27 |
| K862121 | E.W.L. P-TENS/H-WAVE | Electronic Waveform Laboratory, Inc. | 1987-06-17 |
| K862092 | COMFORTRON | M. D. Supply, Inc. | 1986-10-15 |
Legacy Summary#
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FDA Review#
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