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#
- 2027062
- 1314417
- 3008603863
- 3010621964
- 3018762668
- 3005347827
- 3010160370
- 3013226
- 3034669683
- 3008902714
- 1836161
- 3006061749
- 3004874794
- 3006563173
- 3012316249
- 3007127332
- 3013412170
- 3000261882
- 3011587055
- 3005621808
- 3007697981
- 3020614
- 8022890
- 3011353843
- 3003932293
- 3000153466
- 3020751316
- 3042507287
- 2427500
- 3007307487
- 3031369651
- 3010595915
- 3000126629
- 3015191173
- 3030733800
- 3013513837
- 9710020
- 3005783425
- 3016052406
- 3010419931
- 3010439239
- 3012050423
- 3015084765
- 3016452400
- 3013095415
- 3004056932
- 3012971441
- 9616083
- 3010198795
- 3013510193
- 9610861
- 3016618143
- 3009490946
- 3007289408
- 3012307300
- 9710567
- 2182318
- 3010957755
- 3006606984
- 3009429841
- 3010216013
- 3013426279
- 3005998497
- 3005609751
- 2085602
- 3011503227
- 3014610488
- 8022257
- 3006547005
- 3015928685
- 3003528228
- 3018503755
- 3022568093
- 9616354
- 8020785
- 8010042
- 3013188547
- 3004604967
- 3034629649
- 3008264065
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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