The following data is part of a premarket notification filed by I.p.i. Medical Products with the FDA for Ipi Humidifier Chamber.
| Device ID | K993282 |
| 510k Number | K993282 |
| Device Name: | IPI HUMIDIFIER CHAMBER |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | I.P.I. MEDICAL PRODUCTS 3217 N. KILPATRICK AVE. Chicago, IL 60641 |
| Contact | Mazh Said, Ph.d |
| Correspondent | Mazh Said, Ph.d I.P.I. MEDICAL PRODUCTS 3217 N. KILPATRICK AVE. Chicago, IL 60641 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-30 |
| Decision Date | 2000-09-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30351688517054 | K993282 | 000 |