The following data is part of a premarket notification filed by Parks Medical Electronics, Inc. with the FDA for Model 3200 Vascular Mini-lab.
| Device ID | K944495 |
| 510k Number | K944495 |
| Device Name: | MODEL 3200 VASCULAR MINI-LAB |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | PARKS MEDICAL ELECTRONICS, INC. P.O. BOX 5669 Aloha, OR 97006 |
| Contact | Larry D Smurthwaite |
| Correspondent | Larry D Smurthwaite PARKS MEDICAL ELECTRONICS, INC. P.O. BOX 5669 Aloha, OR 97006 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-13 |
| Decision Date | 1995-06-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816787024289 | K944495 | 000 |
| 00816787024272 | K944495 | 000 |
| 00816787024173 | K944495 | 000 |
| 00816787020151 | K944495 | 000 |
| 00816787020144 | K944495 | 000 |
| 00816787020137 | K944495 | 000 |
| 00816787020120 | K944495 | 000 |
| 00816787020113 | K944495 | 000 |
| 00816787020106 | K944495 | 000 |