510(k) K780385
- Device
- Respiratory Therapy Solutions - Flexible
- Applicant
- TRAVENOL LABORATORIES, S.A.
- 510(k) number
- K780385
- Product code
- BTT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-05-16
- Date received
- 1978-03-10
- Regulation
- 868.5450
- Classification name
- Humidifier, Respiratory Gas, (Direct Patient Interface)
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Related Records
Applicant Contact
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers
- 3010272829
- 9680661
- 3016052406
- 3021947238
- 3003898360
- 3011987967
- 3014766741
- 3006636961
- 3042507287
- 8010042
- 1423662
- 1417411
- 3011971979
- 3005587132
- 3018900343
- 3007502289
- 3018094310
- 8030673
- 8043439
- 9617566
- 3018783526
- 8021995
- 3029906224
- 9611500
- 3043709870
- 3017520736
- 3001313714
- 9710644
- 3006606984
- 3029706818
- 1417519
- 3030089838
- 3008264065
- 3011120183
- 3007238566
- 3021039857
- 3008770104
- 3004111573
- 3016723884
- 3012971441
- 3008806809
- 9610849
- 3009129579
- 9611451
- 3010063021
- 3017235290
- 3008567544
- 3043226252
- 3004050971
- 3004365956
- 1526863
- 3004604967
- 1420032
- 3013820501
- 3014499739
- 3006785496
- 3023272766
- 3012316249
- 8043316
- 3006783791
- 2244684
- 3004748541
- 3013095415
- 1225492
- 2028807
- 2518422
- 3030149975
- 8010939
- 1417592
- 3006467300
- 3015537026
- 1625392
- 2523148
- 3006061749
- 2132517
- 3016761372
- 3023209222
- 3012494290
- 9710641
Source Documents
510(k) summary PDF not indicated by FDA
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