Thoracic Drainage Set #55-DB2-G
FDA 510(k) K812746 · J. H. Emerson Co.
510(k) numberK812746
Submission
- Device name
- Thoracic Drainage Set #55-DB2-G
- Applicant
- J. H. Emerson Co.
Mchenry, IL, US - Received
- September 29, 1981
- Decision date
- October 26, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KDQ – Bottle, Collection, Vacuum
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6740
- Specialty
- General Hospital
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| K961287 | Rocket Pleuraseal II Chest Drainage SystemKDQ · Traditional | Rocket Medical Plc | 07/26/1996SE |
| K962168 | Mucus Specimen TrapKDQ · Traditional | Sage Products, Inc. | 07/22/1996SE |
| K950677 | Atrium Dry Suction Control Water Seal Chest DrainKDQ · Traditional | Atrium Medical Corp. | 04/13/1995SE |
| K941818 | PM9000 Vac TrapKDQ · Traditional | Precision Medical, Inc. | 12/12/1994SE |
| K932327 | Thora-Klex 350 ML Pediatric Chest Drainage SystemKDQ · Traditional | Davol, Inc. | 07/13/1993SE |
More from Davol, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K002598 | Emerson Cough Assist Model CA-3000 W/Automatic Timing and Model CM-3000 W/Manual TimingNHJ · Special | 11/22/2000SE |
| K920910 | Oxygen Powered Resuscitator for CPRBTL · Traditional | 01/12/1993SE |
| K924174 | Emerson In-Exsufflator, Models 2-CM & 2-CANHJ · Traditional | 11/17/1992SE |
| K902764 | Emerson 33-AN Negative Pressure Respirator AlarmBYT · Traditional | 11/19/1990SE |
| K896721 | Model 7-AT Treatment ChamberLGM · Traditional | 01/22/1990SE |
| K881808 | Emerson Chest Respirator, Model 33-CREBYT · Traditional | 08/04/1988SE |
| K873489 | Emerson Dispos Thoracic Drainage Set - 551-8000GCX · Traditional | 12/29/1987SE |
| K872937 | 97-TD Emerson Timer/Dimmer ControlIQA · Traditional | 09/24/1987SE |
| K872936 | 97-D Emerson Dimmer ControlIQA · Traditional | 09/24/1987SE |
| K864379 | Emerson 3MV Volume VentilatorCBK · Traditional | 12/15/1986SE |
Questions and answers
When was Thoracic Drainage Set #55-DB2-G cleared by the FDA?
Thoracic Drainage Set #55-DB2-G (K812746) received a 510(k) decision of Substantially Equivalent on October 26, 1981, 27 days after the submission was received.
What is the product code of K812746?
The FDA product code is KDQ – Bottle, Collection, Vacuum, a Class II (moderate risk) device regulated under 21 CFR 880.6740.