The following data is part of a premarket notification filed by Vital Signs, Inc. with the FDA for Cleen-able.
| Device ID | K994044 |
| 510k Number | K994044 |
| Device Name: | CLEEN-ABLE |
| Classification | Blood Pressure Cuff |
| Applicant | VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512 |
| Contact | Anthony Martino |
| Correspondent | Anthony Martino VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512 |
| Product Code | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-29 |
| Decision Date | 2000-02-25 |
| Summary: | summary |