The following data is part of a premarket notification filed by Beta Medical Products, Inc. with the FDA for Beta Multi-procedure Mobile Urological Table, Model S5005.
| Device ID | K954278 |
| 510k Number | K954278 |
| Device Name: | BETA MULTI-PROCEDURE MOBILE UROLOGICAL TABLE, MODEL S5005 |
| Classification | Table, Cystometric, Electric |
| Applicant | BETA MEDICAL PRODUCTS, INC. 530 SOUTH MAIN ST., BLDG. 17 Akron, OH 44311 -1010 |
| Contact | Kevin Benoit |
| Correspondent | Kevin Benoit BETA MEDICAL PRODUCTS, INC. 530 SOUTH MAIN ST., BLDG. 17 Akron, OH 44311 -1010 |
| Product Code | MMZ |
| CFR Regulation Number | 876.4890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-13 |
| Decision Date | 1995-10-02 |