The following data is part of a premarket notification filed by Datex Division Instrumentarium Corp. with the FDA for Deltatrac(tm) Metabolic Monitor.
| Device ID | K864603 |
| 510k Number | K864603 |
| Device Name: | DELTATRAC(TM) METABOLIC MONITOR |
| Classification | Computer, Oxygen-uptake |
| Applicant | DATEX DIVISION INSTRUMENTARIUM CORP. 127 UPHAM ST. Melrose, MA 02176 |
| Contact | Hannu Ahjopalo |
| Correspondent | Hannu Ahjopalo DATEX DIVISION INSTRUMENTARIUM CORP. 127 UPHAM ST. Melrose, MA 02176 |
| Product Code | BZL |
| CFR Regulation Number | 868.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-24 |
| Decision Date | 1987-03-17 |