The following data is part of a premarket notification filed by Delmed, Inc. with the FDA for Intertech Sterile Water For Inhalation.
| Device ID | K881184 |
| 510k Number | K881184 |
| Device Name: | INTERTECH STERILE WATER FOR INHALATION |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | DELMED, INC. 120 ALBANY ST. P.O. BOX 2623 New Brunswick, NJ 08903 |
| Contact | Ronald Guido |
| Correspondent | Ronald Guido DELMED, INC. 120 ALBANY ST. P.O. BOX 2623 New Brunswick, NJ 08903 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-21 |
| Decision Date | 1988-05-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810083350349 | K881184 | 000 |
| 00810083350325 | K881184 | 000 |
| 00810083350295 | K881184 | 000 |
| 00810083350264 | K881184 | 000 |