510(k) K760080
- Device
- CANNULA, NASAL, FOR OXYGEN
- Applicant
- INSPIRON CORP.
- 510(k) number
- K760080
- Product code
- CAT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1976-07-15
- Date received
- 1976-06-21
- Regulation
- 868.5340
- Classification name
- Cannula, Nasal, Oxygen
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3007963782
- 3003528228
- 2225311
- 3003902679
- 9611500
- 3010580321
- 3016734145
- 3007697981
- 3013513837
- 3011587055
- 3016701404
- 3015191173
- 3030446844
- 3042617724
- 3015058854
- 3015772781
- 2648727
- 3004056932
- 3007127332
- 3013412170
- 3010419931
- 3010595915
- 3004748541
- 3008603863
- 3012311599
- 3006787036
- 3003882387
- 3034669683
- 3018366470
- 9710567
- 3036979319
- 3043648593
- 3009771213
- 3010160370
- 3013496867
- 3004874794
- 3005621808
- 3008676146
- 3015495690
- 3008791328
- 3015084765
- 3030733800
- 3022568093
- 3015140199
- 3021039857
- 8043685
- 3007649127
- 3009831876
- 3021286079
- 3007573469
- 8043316
- 3023209222
- 2028807
- 3008776780
- 3010156053
- 8022978
- 3008264065
- 3007289408
- 3017202422
- 3013055504
- 3010583519
- 3003932293
- 3015928685
- 3006606984
- 8020785
- 3000153466
- 3013510193
- 3010287621
- 3030648305
- 2025917
- 3011353843
- 3007681502
- 9616991
- 3012316249
- 2183615
- 3005587132
- 3016195240
- 3006563173
- 2027062
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CAT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K011125 | NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI | Hudson Respiratory Care, Inc. | 2001-06-13 |
| K935533 | NASAL CANNULA | Puritas Health Care, Inc. | 1994-02-03 |
| K922397 | 4 SURE TM NASAL OXYGEN CANNULA | Boston Pacific Medical, Inc. | 1993-03-18 |
| K921496 | SKIN SAVER(TM) TUBING HOLDER, MODEL 1921 MODIFIED | Alpine Specialties, Inc. | 1992-08-14 |
| K920573 | CANNULA NASAL OXYGEN | B & F Medical Products, Inc. | 1992-08-11 |
| K913421 | NASAL OXYGEN CANNULA, 81585, 81587 & 81589 | Specialty Packaging Producs, Inc. | 1991-10-18 |
| K912197 | SKIN SAVER(TM) TUBING HOLDER, MODEL 467 | Alpine Specialties, Inc. | 1991-08-20 |
| K911740 | SALTER LABS NEONATAL NASAL OXYGEN CANNULA | Salter Labs | 1991-07-24 |
| K902420 | CATHETER, NASAL, OXYGEN | Gainor Medical Europe, Ltd. | 1991-04-17 |
| K896036 | THE COMFORTABLE CANNULA | Comfortable Concepts Corp. | 1989-11-17 |
| K892435 | KENDALL CURITY OXYGEN NASAL CANNULA | The Kendal Co. | 1989-06-12 |
| K884149 | COMFORT STRAP | Comfort Strap Co. | 1988-10-21 |
| K863431 | OXYGEN CANNULA EAR WRAP (STYLE A) | Salter Labs | 1986-09-18 |
| K863432 | OXYGEN CANNULA EAR WRAP (STYLE B) | Salter Labs | 1986-09-18 |
| K860535 | UNILATERAL OXYGEN DELIVERY SYSTEM (ULODS) | Andover Medical, Inc. | 1986-04-01 |
Legacy Summary#
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FDA Review#
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