510(k) K942485
- Device
- MDT UROLOGY TABLE
- Applicant
- MDT CORP., INC.
- 510(k) number
- K942485
- Product code
- MMZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-08-26
- Date received
- 1994-05-25
- Regulation
- 876.4890
- Classification name
- Table, Cystometric, Electric
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARK N SMITH
- Address
- 1777 E. Henrietta Rd. Rochester NY US 14623 14623
FDA Registration Numbers#
- 3010193531
- 3002808176
- 2243057
- 1054241
- 1043214
- 1223864
- 3013885240
- 1055236
- 2529571
- 3031564213
- 3017636737
- 3010496070
- 2182318
- 9612448
- 3029906632
- 1825014
Source Documents#
Other 510(k) Records For Product Code MMZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K033335 | LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUS | Siemens Medical Solutions USA, Inc. | 2003-11-25 |
| K954278 | BETA MULTI-PROCEDURE MOBILE UROLOGICAL TABLE, MODEL S5005 | Beta Medical Products, Inc. | 1995-10-02 |
| K942445 | SYNERGY II | Synectics Medical, Inc. | 1994-11-22 |
Legacy Summary#
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FDA Review#
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