The following data is part of a premarket notification filed by Mauna Loa Medical, Inc. with the FDA for Mauna Loa Enhanced Heated Breathing Circuit.
| Device ID | K904538 |
| 510k Number | K904538 |
| Device Name: | MAUNA LOA ENHANCED HEATED BREATHING CIRCUIT |
| Classification | Circuit, Breathing (w Connector, Adaptor, Y Piece) |
| Applicant | MAUNA LOA MEDICAL, INC. 3305 SPRINGMOUNTAIN RD., #60 Las Vegas, NV 89102 |
| Contact | James Weigl |
| Correspondent | James Weigl MAUNA LOA MEDICAL, INC. 3305 SPRINGMOUNTAIN RD., #60 Las Vegas, NV 89102 |
| Product Code | CAI |
| CFR Regulation Number | 868.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-04 |
| Decision Date | 1991-04-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10709078005463 | K904538 | 000 |
| 00709078005381 | K904538 | 000 |
| 10709078004497 | K904538 | 000 |
| 00709078004049 | K904538 | 000 |
| 00709078007071 | K904538 | 000 |
| 10709078007849 | K904538 | 000 |
| 10709078004787 | K904538 | 000 |
| 10709078008884 | K904538 | 000 |