510(k) K811413
- Device
- DABC NONCONDUCTIVE PEDIAT. ANESTH. CIR
- Applicant
- AIRCO/OHIO MEDICAL PRODUCTS
- 510(k) number
- K811413
- Product code
- CAI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-06-02
- Date received
- 1981-05-19
- Regulation
- 868.5240
- Classification name
- Circuit, Breathing (w Connector, Adaptor, Y Piece)
- 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#
- 3014615028
- 3004050971
- 3010131137
- 8010939
- 9616088
- 1218704
- 1061124
- 3013783488
- 3008693658
- 3045058049
- 3018366470
- 1319447
- 3019793765
- 3006157842
- 9610861
- 3006547005
- 3010889742
- 1000604079
- 3005998497
- 3015537026
- 8030673
- 2020550
- 3011137372
- 3017171849
- 2022648
- 3010817335
- 3010707607
- 3013576541
- 3008294339
- 9680661
- 3010202439
- 3001650535
- 3005587132
- 3010621964
- 3012050423
- 3021039857
- 3015058854
- 2648727
- 3011185837
- 3016764932
- 1924066
- 3006061749
- 3010397428
- 3018762668
- 9610617
- 1722746
- 9617566
- 3003902679
- 3013298431
- 3010400865
- 3010838917
- 8010042
- 3013550220
- 9710644
- 3038562397
- 3034629649
- 3021947238
- 1417592
- 3004122598
- 3016634999
- 9681384
- 3008867836
- 3029706818
- 3010187802
- 9610849
- 3015907115
- 1824226
- 9710391
- 3006534321
- 1024404
- 3011986317
- 3009107690
- 3001313714
- 8044169
- 3015142721
- 3003449582
- 3017178358
- 3013557562
- 3043619925
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CAI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K954480 | CONDENSATE COLLECTION KIT | Nova-Ventrx | 1995-12-29 |
| K953788 | UNICOR, INC. GAS SAMPLING LINES & CONNECTORS | Unicor, Inc. | 1995-09-19 |
| K953787 | UNICOR, INC. ADULT ANESTHESIA BREATHING CIRCUIT | Unicor, Inc. | 1995-09-19 |
| K952020 | PRIMA PEDIATRIC ANESTHESIA CIRCUITS | Prima, Inc. | 1995-05-22 |
| K952019 | PRIMA ADULT GAS SAMPLING CIRCUITS | Prima, Inc. | 1995-05-22 |
| K952018 | PRIMA COAXIAL CIRCUITS | Prima, Inc. | 1995-05-22 |
| K952017 | PRIMA MAPLESON D CIRCUIT | Prima, Inc. | 1995-05-22 |
| K952016 | PRIMA PEDIATRIC GAS SAMPLING CIRCUITS | Prima, Inc. | 1995-05-22 |
| K952014 | PRIMA ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS | Prima, Inc. | 1995-05-22 |
| K952009 | PRIMA PEDIATRIC TEMPERATURE MONITORING CIRCUITS | Prima, Inc. | 1995-05-19 |
| K945565 | SPIRO-FLEX | Inhalation Plastics | 1995-01-13 |
| K932288 | NEONATAL BREATHING CIRCUIT MODIFICATION | Simplex Medical Systems, Inc. | 1994-12-30 |
| K945984 | MERIDIAN MEDICAL SYSTEMS MAPLESON D AND MODIFIED JACKSON REESE CIRCUITS | Meridian Medical Systems, Inc. | 1994-12-27 |
| K944533 | PRIMA, INC. ADULT ANESTHESIA CIRCUIT | Prima, Inc. | 1994-11-29 |
| K945314 | CLEVELAND TUBING, INC. EXPANDABLE/COLLAPSIBLEMEDICAL TUBING | Cleveland Tubing, Inc. | 1994-11-18 |
Legacy Summary#
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FDA Review#
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