The following data is part of a premarket notification filed by Criticare Technologies Corp. with the FDA for Patientcare 1000.
| Device ID | K861324 |
| 510k Number | K861324 |
| Device Name: | PATIENTCARE 1000 |
| Classification | Pump, Infusion |
| Applicant | CRITICARE TECHNOLOGIES CORP. 1855 DEMING WAY Sparks, NV 89431 |
| Contact | Frank Ferguson |
| Correspondent | Frank Ferguson CRITICARE TECHNOLOGIES CORP. 1855 DEMING WAY Sparks, NV 89431 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-08 |
| Decision Date | 1986-06-09 |