The following data is part of a premarket notification filed by Deroyal Industries, Inc. with the FDA for Deroyal Sterile Neonatal Blood Pressure Cuff.
| Device ID | K991525 |
| 510k Number | K991525 |
| Device Name: | DEROYAL STERILE NEONATAL BLOOD PRESSURE CUFF |
| Classification | Blood Pressure Cuff |
| Applicant | DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849 |
| Contact | Lois Marsh |
| Correspondent | Lois Marsh DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849 |
| Product Code | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-03 |
| Decision Date | 1999-07-20 |
| Summary: | summary |