The following data is part of a premarket notification filed by Hospital Concepts, Inc. with the FDA for Hci Meconium Aspirator.
| Device ID | K862132 |
| 510k Number | K862132 |
| Device Name: | HCI MECONIUM ASPIRATOR |
| Classification | Catheters, Suction, Tracheobronchial |
| Applicant | HOSPITAL CONCEPTS, INC. 2701 W. ALAMEDA AVE., SUITE 406 Burbank, CA 91505 |
| Contact | Pradip Choksi |
| Correspondent | Pradip Choksi HOSPITAL CONCEPTS, INC. 2701 W. ALAMEDA AVE., SUITE 406 Burbank, CA 91505 |
| Product Code | BSY |
| CFR Regulation Number | 868.6810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-04 |
| Decision Date | 1986-06-19 |