The following data is part of a premarket notification filed by Linde Medical Sensors Ag with the FDA for Microgas 7650 Transcutaneous Monitor.
| Device ID | K003943 |
| 510k Number | K003943 |
| Device Name: | MICROGAS 7650 TRANSCUTANEOUS MONITOR |
| Classification | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia |
| Applicant | LINDE MEDICAL SENSORS AG AUSTRASSE 25 Basel, CH 4051 |
| Contact | Jean-pierre Palma |
| Correspondent | Jean-pierre Palma LINDE MEDICAL SENSORS AG AUSTRASSE 25 Basel, CH 4051 |
| Product Code | KLK |
| CFR Regulation Number | 868.2500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-21 |
| Decision Date | 2001-05-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05700693095257 | K003943 | 000 |
| 05700693095240 | K003943 | 000 |
| 05700693095226 | K003943 | 000 |
| 05700693095202 | K003943 | 000 |
| 05700693095189 | K003943 | 000 |