510(k) K896897
- Device
- VENTLAB ANESTHESIA CIRCUIT AC 6000
- Applicant
- VENTLAB CORP.
- 510(k) number
- K896897
- Product code
- CAI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-01-26
- Date received
- 1989-12-08
- 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#
- Contact
- GREGORY LAU
- Address
- 221 Gracie Pl. Hackensack NJ US 07601 07601
FDA Registration Numbers#
- 3044994756
- 3015537026
- 3011587055
- 3019793765
- 3030446844
- 3012307300
- 3020460367
- 3010580321
- 3008867836
- 3006157842
- 9613910
- 3003862188
- 3045058049
- 3003449582
- 3004111573
- 3031369651
- 3006606984
- 3006984712
- 8022265
- 3006446479
- 3021947238
- 8044169
- 3021039857
- 9710644
- 9617604
- 9616088
- 2938401
- 3011137372
- 3017202422
- 2518422
- 9616445
- 1043214
- 3007127332
- 3043619925
- 3005998497
- 8021995
- 3010834934
- 3003902679
- 3014437893
- 3001415205
- 8044004
- 3006783791
- 9611451
- 1420751
- 3014579161
- 1423395
- 2523320
- 3018783526
- 3010621964
- 3018762668
- 9610861
- 3006897516
- 3008258694
- 2028807
- 3016634999
- 3017828726
- 2112667
- 3000126629
- 3011185837
- 3018366470
- 3013507143
- 2518157
- 9710391
- 2936999
- 9610849
- 1824226
- 3015907115
- 3015058854
- 3010683054
- 3021244152
- 8010042
- 3002905553
- 3010515776
- 3013412170
- 3038195661
- 3003898360
- 3023272766
- 3001650535
- 3011986317
- 3004050971
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#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases