The following data is part of a premarket notification filed by Baltimore Therapeutic Equipment Co. with the FDA for The Bte Ws30.
| Device ID | K933611 |
| 510k Number | K933611 |
| Device Name: | THE BTE WS30 |
| Classification | Exerciser, Measuring |
| Applicant | BALTIMORE THERAPEUTIC EQUIPMENT CO. 7455 L NEW RIDGE RD. Hanover, MD 21076 |
| Contact | John Vermette |
| Correspondent | John Vermette BALTIMORE THERAPEUTIC EQUIPMENT CO. 7455 L NEW RIDGE RD. Hanover, MD 21076 |
| Product Code | ISD |
| CFR Regulation Number | 890.5360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-19 |
| Decision Date | 1994-06-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850390007243 | K933611 | 000 |
| 10850390007236 | K933611 | 000 |