DIATHERMY DEVICE-MICROFOCUS
FDA 510(k) clearance K941567 · decided 1996-04-22
Clearance details
- K-number
- K941567
- Device name
- DIATHERMY DEVICE-MICROFOCUS
- Applicant
- Cheung Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-04-01
- Decision date
- 1996-04-22
- Days to decision
- 752 days
- Clearance type
- Traditional
- Product code
- IOA
- Device class
- 2
- Regulation number
- 890.5275
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Columbia, MD, 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 |
|---|---|---|
| NEMECTRON MICROWAVE (K895000) | Nemectron Medical, Inc. | 1990-07-27 |
| SIEMENS RADIOTHERM 706, MICROWAVE THERAPY UNIT (K862029) | Elmed, Inc. | 1986-07-16 |
| THERMOTRON 918 (K860082) | Medical Microwave Research Corp. | 1986-03-27 |
Recalls involving this device
No recalls on record reference this clearance.