IST RESPONSE MANUAL RESUSCITATOR, MODELS, 008000, 008003,008006— 510(k) K992057
Substantially EquivalentSims Portex, Inc.
FDA 510(k) clearance K992057 for IST RESPONSE MANUAL RESUSCITATOR, MODELS, 008000, 008003,008006, Substantially Equivalent on 1999-09-13. Applicant: Sims Portex, Inc.. Device class: 2.
Clearance details
- Applicant
- Sims Portex, Inc.
- Product code
- Code BTM
- Device class
- Class 2
- Regulation
- 21 CFR 868.5915
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Keene, NH, US
Recent devices under product code BTM
view allMore clearances from Sims Portex, Inc.
view all- K011925 — HYPODERMIC NEEDLE-PRO NEEDLE WITH NEEDLE PROTECTION DEVICE; HYPODERMIC NEEDLE-PRO SYRINGE & NEEDLE WITH NEEDLE PROTECTIO
- K002201 — ELECTROSTATIC HYDROPHOBIC BREATHING FILTER
- K002506 — BREATHING FILTER FOR DISPOSABLE ANESTHESIA BREATHING CIRCUIT
- K001318 — CPAP SYSTEM, MODEL 102001
- K993619 — CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCK
Adverse events under product code BTM
product code BTM- Death
- 19
- Other
- 2
- Total
- 21
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.