The following data is part of a premarket notification filed by Medical Associated Services, Inc. with the FDA for Peds Water Filled Catheter/transducer System.
| Device ID | K893845 |
| 510k Number | K893845 |
| Device Name: | PEDS WATER FILLED CATHETER/TRANSDUCER SYSTEM |
| Classification | Calculator, Pulmonary Function Data |
| Applicant | MEDICAL ASSOCIATED SERVICES, INC. P.O. BOX 530 Hatfield, PA 19440 |
| Contact | Box 530 |
| Correspondent | Box 530 MEDICAL ASSOCIATED SERVICES, INC. P.O. BOX 530 Hatfield, PA 19440 |
| Product Code | BZC |
| CFR Regulation Number | 868.1880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-25 |
| Decision Date | 1989-10-27 |