The following data is part of a premarket notification filed by Worldwide Medical Technologies, Llc with the FDA for Spiritus(tm) Respiratory System #srs 001.
| Device ID | K020641 |
| 510k Number | K020641 |
| Device Name: | SPIRITUS(TM) RESPIRATORY SYSTEM #SRS 001 |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | WORLDWIDE MEDICAL TECHNOLOGIES, LLC 3178 KEEN DR. Waycross, GA 31503 |
| Contact | Jonathan Lee |
| Correspondent | Jonathan Lee WORLDWIDE MEDICAL TECHNOLOGIES, LLC 3178 KEEN DR. Waycross, GA 31503 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-27 |
| Decision Date | 2002-10-29 |
| Summary: | summary |