510(k) K811789
- Device
- OECO NASAL CANNULA
- Applicant
- OECO
- 510(k) number
- K811789
- Product code
- CAT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-07-02
- Date received
- 1981-06-24
- 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#
- 3005327291
- 3015772781
- 9616354
- 3030733800
- 8040278
- 3010160370
- 3015060216
- 3018114218
- 3030446844
- 2427500
- 3017202422
- 3007649127
- 3014610488
- 2085602
- 9611451
- 3013909820
- 3012050423
- 3031184338
- 9613418
- 3011600579
- 3043460907
- 3008264065
- 3008496560
- 3000153466
- 3007092328
- 8010042
- 1225580
- 8022978
- 3015907115
- 3004604967
- 3018366470
- 8030673
- 3041276591
- 3006395447
- 3020751316
- 3034669683
- 3022114827
- 3007307487
- 3013576541
- 3029706818
- 3008570547
- 3013557562
- 3005873568
- 3006783791
- 3011137372
- 3008676146
- 3018503755
- 3036979319
- 3009831876
- 8043316
- 8022257
- 3003965134
- 2025917
- 3010402691
- 3004748541
- 3004122598
- 3007697981
- 3011353843
- 3010131137
- 3023209222
- 3045058049
- 3009771213
- 3008693658
- 3012316249
- 3017385563
- 3008603863
- 1000484830
- 3020460367
- 3005652389
- 9710020
- 3004488394
- 3003528228
- 3010156053
- 3003862188
- 3003932293
- 3016052406
- 3044994756
- 3015277818
- 3005609751
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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