The following data is part of a premarket notification filed by Pa Medical Corp. with the FDA for Pressure Infusor #1900.
| Device ID | K860084 |
| 510k Number | K860084 |
| Device Name: | PRESSURE INFUSOR #1900 |
| Classification | Infusor, Pressure, For I.v. Bags |
| Applicant | PA MEDICAL CORP. 1512 NASHVILLE HIGHWAY P.O. BOX 1286 Columbia, TN 38401 |
| Contact | Bailey Vaughn |
| Correspondent | Bailey Vaughn PA MEDICAL CORP. 1512 NASHVILLE HIGHWAY P.O. BOX 1286 Columbia, TN 38401 |
| Product Code | KZD |
| CFR Regulation Number | 880.5420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-09 |
| Decision Date | 1986-03-18 |