Pediatric Humidifier Tube W/ Temperature Port
FDA 510(k) K884525 · Intertech/Ohio
510(k) numberK884525
Submission
- Device name
- Pediatric Humidifier Tube W/ Temperature Port
- Applicant
- Intertech/Ohio
Fort Myers, FL, US - Received
- October 27, 1988
- Decision date
- December 16, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BZO – Set, Tubing And Support, Ventilator (W Harness)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5975
- Specialty
- Anesthesiology
Other 510(k)s with product code BZO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K953784 | Unicor, Inc. Corrugated TubingBZO · Traditional | Unicor, Inc. | 09/19/1995SE |
| K953785 | Unicor, Inc. Ventilator HosesBZO · Traditional | Unicor, Inc. | 09/18/1995SE |
| K952022 | Prima Volumn VentilatorssBZO · Traditional | Prima, Inc. | 05/22/1995SE |
| K952012 | Prima Custom Anestesia CircuitBZO · Traditional | Prima, Inc. | 05/22/1995SE |
| K952011 | Prima Breathing BagsBZO · Traditional | Prima, Inc. | 05/22/1995SE |
| K952010 | Prima Ventilator HosesBZO · Traditional | Prima, Inc. | 05/22/1995SE |
| K945740 | Infant Flow SystemBZO · Traditional | Hamilton Medical, Inc. | 03/23/1995SE |
| K944531 | Prima, Inc. Corrugated TubingBZO · Traditional | Prima, Inc. | 12/02/1994SE |
| K942572 | Volume VentilatorBZO · Traditional | Med-Plastics Intl., Inc. | 06/10/1994SE |
| K942569 | Ventilator HoseBZO · Traditional | Med-Plastics Intl., Inc. | 06/10/1994SE |
More from Med-Plastics Intl., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K895144 | Intertech Metered Dose ElbowBZA · Traditional | 10/19/1989SE |
| K890346 | Intertech Universal Hydrophobic FilterCAH · Traditional | 03/01/1989SE |
| K884526 | Adult Resuscitator with Mask and FilterBTM · Traditional | 11/16/1988SE |
| K882204 | Resuscitator Valve Assembly W/FilterCBP · Traditional | 07/08/1988SE |
| K880394 | First Response Pediatric Emergency ResuscitatorBTM · Traditional | 02/29/1988SE |
| K863033 | Patient Gas Sampling KIT/5STAND Alone VersionsBZO · Traditional | 08/20/1986SE |
| K862020 | Heat/Moisture Exchanger, Hme, W/Integral FilterBYD · Traditional | 06/30/1986SE |
| K860650 | 90 Degree Elbow & Straight ConnectorBZA · Traditional | 03/28/1986SE |
| K861056 | Straight Adapt W/Temp Sensing Port/Closure PlugBZA · Traditional | 03/27/1986SE |
Questions and answers
When was Pediatric Humidifier Tube W/ Temperature Port cleared by the FDA?
Pediatric Humidifier Tube W/ Temperature Port (K884525) received a 510(k) decision of Substantially Equivalent on December 16, 1988, 50 days after the submission was received.
What is the product code of K884525?
The FDA product code is BZO – Set, Tubing And Support, Ventilator (W Harness), a Class I (low risk) device regulated under 21 CFR 868.5975.