BETA MULTI-PROCEDURE MOBILE UROLOGICAL TABLE, MODEL S5005
FDA 510(k) clearance K954278 · decided 1995-10-02
Clearance details
- K-number
- K954278
- Device name
- BETA MULTI-PROCEDURE MOBILE UROLOGICAL TABLE, MODEL S5005
- Applicant
- Beta Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-09-13
- Decision date
- 1995-10-02
- Days to decision
- 19 days
- Clearance type
- Traditional
- Product code
- MMZ
- Device class
- 2
- Regulation number
- 876.4890
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Akron, OH, 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 |
|---|---|---|
| LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUS (K033335) | Siemens Medical Solutions USA, Inc. | 2003-11-25 |
| SYNERGY II (K942445) | Synectics Medical, Inc. | 1994-11-22 |
| MDT UROLOGY TABLE (K942485) | Mdt Corp., Inc. | 1994-08-26 |
Recalls involving this device
No recalls on record reference this clearance.