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 |