The following data is part of a premarket notification filed by Mauna Loa Medical, Inc. with the FDA for Lavabed System & Chamber, Lavapak Temp. Control.
| Device ID | K870173 |
| 510k Number | K870173 |
| Device Name: | LAVABED SYSTEM & CHAMBER, LAVAPAK TEMP. CONTROL |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | MAUNA LOA MEDICAL, INC. 3387 CHICAGO AVE. Riverside, CA 92507 |
| Contact | James Weigl |
| Correspondent | James Weigl MAUNA LOA MEDICAL, INC. 3387 CHICAGO AVE. Riverside, CA 92507 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-14 |
| Decision Date | 1987-04-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00709078006012 | K870173 | 000 |
| 00709078001208 | K870173 | 000 |
| 10709078001199 | K870173 | 000 |
| 10709078001182 | K870173 | 000 |
| 10709078001175 | K870173 | 000 |
| 00709078001161 | K870173 | 000 |
| 10709078008181 | K870173 | 000 |
| 00709078012198 | K870173 | 000 |
| 10709078012188 | K870173 | 000 |
| 00709078012150 | K870173 | 000 |
| 00709078012136 | K870173 | 000 |
| 00709078001864 | K870173 | 000 |
| 10709078001915 | K870173 | 000 |
| 10709078001922 | K870173 | 000 |
| 00709078006005 | K870173 | 000 |
| 10709078005029 | K870173 | 000 |
| 00709078004452 | K870173 | 000 |
| 10709078002318 | K870173 | 000 |
| 00709078002304 | K870173 | 000 |
| 10709078002295 | K870173 | 000 |
| 10709078002288 | K870173 | 000 |
| 10709078002271 | K870173 | 000 |
| 00709078002229 | K870173 | 000 |
| 00709078002205 | K870173 | 000 |
| 00850018561648 | K870173 | 000 |