The following data is part of a premarket notification filed by Zewa, Inc. with the FDA for Delwa-star Pacifier Thermometer.
| Device ID | K952765 |
| 510k Number | K952765 |
| Device Name: | DELWA-STAR PACIFIER THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | ZEWA, INC. MCDERMOTT, WILL & EMERY 1850 K ST., N.W., SUITE 500 Washington, DC 20006 |
| Contact | David L Rosen |
| Correspondent | David L Rosen ZEWA, INC. MCDERMOTT, WILL & EMERY 1850 K ST., N.W., SUITE 500 Washington, DC 20006 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-04 |
| Decision Date | 1995-10-13 |