MODEL EM-IR
FDA 510(k) clearance K810528 · decided 1981-03-31
Clearance details
- K-number
- K810528
- Device name
- MODEL EM-IR
- Applicant
- Myo-Tronics Research, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-02-26
- Decision date
- 1981-03-31
- Days to decision
- 33 days
- Clearance type
- Traditional
- Product code
- KZM
- Device class
- 2
- Regulation number
- 890.1375
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| TEETHAN 2.0 (K161716) | Bts S.P.A. | 2016-12-21 |
| M-SCAN (K130158) | Bio-Research Associates, Inc. | 2013-07-25 |
| GRINDCARE MEASURE (K113677) | Medotech A/S | 2012-04-05 |
| BIOEMG III (K082927) | Bio-Research Associates, Inc. | 2009-02-06 |
| DOLOTENS DENTAL TM 1 (K043373) | Neuromuscular Technologies, Inc. | 2005-09-02 |
| BITESTRIP (K030869) | S.L.P. , Ltd. | 2004-05-14 |
| BIOEMG II AND BIOJVA (K003176) | Bio-Research Associates, Inc. | 2001-01-04 |
| MODEL K7 EVALUATION DEVICE (K003287) | Myotronics-Noromed, Inc. | 2000-11-06 |
| MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I (K992694) | Myotronics-Noromed, Inc. | 1999-09-10 |
| BIOPAK MEASUREMENT SYSTEM (K981563) | Bio-Research Associates, Inc. | 1998-09-15 |
| K6-1 DIAGNOSTIC SYSTEM VERSION 3.1 (K944134) | Myo-Tronics, Inc. | 1994-12-09 |
| K6-I DIAGNOSTIC SYSTEM (K922456) | Myo-Tronics, Inc. | 1994-06-09 |
Recalls involving this device
No recalls on record reference this clearance.