Safe Response Mouth-To-Mask Resuscitator, Pediatric
FDA 510(k) K952169 · Intertech Resources, Inc.
510(k) numberK952169
Submission
- Device name
- Safe Response Mouth-To-Mask Resuscitator, Pediatric
- Applicant
- Intertech Resources, Inc.
Fort Myers, FL, US - Received
- May 8, 1995
- Decision date
- June 8, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- BTM – Ventilator, Emergency, Manual (Resuscitator)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5915
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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| K170663 | Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount…BTM · Traditional | Foremount Enterprise Co., Ltd. | 05/11/2018SE |
| K152931 | Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II…BTM · Abbreviated | Ambu A/S | 08/29/2016SE |
| K132172 | Neonatalie ResuscitatorBTM · Abbreviated | Laerdal Medical A/S | 01/15/2015SE |
| K112852 | Babi Plus Neonatal Resuscitation BagBTM · Traditional | A Plus Medical | 01/13/2012SE |
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Questions and answers
When was Safe Response Mouth-To-Mask Resuscitator, Pediatric cleared by the FDA?
Safe Response Mouth-To-Mask Resuscitator, Pediatric (K952169) received a 510(k) decision of Substantially Equivalent on June 8, 1995, 31 days after the submission was received.
What is the product code of K952169?
The FDA product code is BTM – Ventilator, Emergency, Manual (Resuscitator), a Class II (moderate risk) device regulated under 21 CFR 868.5915.