510(k) K840897
- Device
- OXYGEN TUBING
- Applicant
- MEDICAL TECHNOLOGIES OF GEORGIA
- 510(k) number
- K840897
- Product code
- CAT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-03-16
- Date received
- 1984-02-27
- 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#
- 8022257
- 3011987967
- 3013557562
- 3005873568
- 3043648593
- 9710641
- 2025917
- 3010131137
- 3004122598
- 3005621808
- 3006061749
- 3013783488
- 3015276780
- 3029706818
- 3018762668
- 3006547005
- 3013426279
- 9681409
- 3007307487
- 3008693658
- 3049808762
- 3042507287
- 3007207474
- 2427500
- 3015277818
- 3003674698
- 3010439239
- 3010156053
- 3005273623
- 3010882708
- 3030536844
- 3043460907
- 3038139564
- 3015191173
- 1000484830
- 3036979319
- 3006899153
- 3033814505
- 3010248787
- 3016734145
- 3006606984
- 3004604967
- 3008806809
- 3014615175
- 3015060216
- 3018783526
- 3005652389
- 3001313714
- 1836161
- 3034669683
- 1422443
- 2028807
- 8010042
- 3013550220
- 3042970959
- 3013000203
- 3015140199
- 3016618143
- 3012316249
- 3011529314
- 1417592
- 3003932293
- 3005767446
- 3008902714
- 3009831876
- 3004748541
- 3014610488
- 3004488394
- 3017609572
- 3007649127
- 3016068274
- 2025816
- 3022106572
- 3008603863
- 3005327291
- 9616567
- 3009490946
- 3010216013
- 3010419931
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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